Protocol Index	

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RESEARCH PRO00021210 NIRAVATH DS8201-A-U301	

Types:      Research Oncology Treatment
Synonyms:  DS 8201 A, DS-8201-A, U301, HER2 +, PRO21210, 21210

Pre Study Screening	Repeat 1 time	Cycle length: 28 days	-28 to -1 days Prior to Randomization	Perform every 1 day x1		Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --			Provider Communication
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Declaration of Investigator's choice paradigm
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo 3D with Contrast as appropriate
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
				-14 to -1 days Prior to Randomization	Perform every 1 day x1		Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
				-3 to -1 days Prior to Randomization	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	History and Physical
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
				Randomization (1:1 randomization to either DS-8201A or Investigator’s choice)	Perform every 1 day x1		Provider Communication
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	o Absolute neutrophil count (ANC) GREATER than or EQUAL to 1,500/mm3 
o Platelets GREATER than or EQUAL to 100,000/mm3, Hemoglobin GREATER than or EQUAL to 8 g/dL
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	o Serum creatinine LESS than or EQUAL to 1.5 X upper limit of normal (ULN) OR Measured or calculated (CrCl should be calculated per institutional standard) 
o Creatinine clearance (CrCl) (glomerular filtration rate can be used in place of creatinine or CrCl) GREATER than or EQUAL to 60 mL/min for subject with creatinine levels GREATER than  1.5 X institutional ULN 
o Glomerular filtration rate (GFR) GREATER than or EQUAL to  30 mL/min/1.73 m2
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o Serum total bilirubin LESS than or EQUAL to  1.5 X ULN. Known Gilbert syndrome is allowed if total bilirubin is LESS than or EQUAL to 3 X ULN 
o ALT and AST and ALP LESS than or EQUAL to  2.5 X ULN OR LESS than or EQUAL to  5 X ULN for subjects with liver metastases, Lipase LESS than 2 X ULN 
o International normalized ratio (INR) and partial thromboplastin time (PTT) or activated PTT (aPTT) LESS than or EQUAL to 1.5 X ULN unless subject is receiving anticoagulant therapy
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Serum Pregnancy test must be negative prior to study drug administration
			Nursing Orders
☐	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	For Trastuzumab/capecitabine (SOC)
o Trastuzumab 8 mg/kg IV loading dose on the first day of treatment followed by 6 mg/kg every 21 d (+/-  2 day)
o Capecitabine 1250 mg/m2 administered orally (PO) twice daily approximately 12 h apart on Days 1 to 14 of a 21 d (± 2 d) schedule
		☐	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Please provide patient with prescription for Capecitabine 1250 mg/m2 administered orally (PO) twice daily approximately 12 hours apart on Days 1 to 14 of a 21 d (± 2 d) schedule
			Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	For Lapatinib/capecitabine (SOC)
o Lapatinib 1250 mg PO daily
o Capecitabine 1000 mg/m2 PO twice daily approximately 12 h apart on Days 1 to 14 of a 21 d (± 2 d) schedule
		☐	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Please provide patient with prescriptions for Lapatinib 1250 mg PO daily AND Capecitabine 1000 mg/m2 PO twice daily approximately 12 hours apart on Days 1 to 14 of a 21 d (± 2 d) schedule
					
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 8	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 14	Repeat 1 time	Cycle length: 40 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☑	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Line Flush
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.			Nursing Orders
☐	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201-A-U301 Study Drug.			Chemotherapy
☐	INV-DS8201a  (DS8201a-U301 study/Niravath/Pro00021210) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse using 0.2 micron inline filter, and protect from light. Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201-A-U301 Study Drug.		☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Line Flush
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
☐	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
☐	INV-Trastuzumab (DS8201a-U301 study/Niravath/Pro00021210) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	NOT compatible with D5W.
Keep refrigerated until use.  Start infusion by no later than __________ hours.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TRASTUZUMAB 440 MG SOLUTION FOR INJECTION (DS8201A-U301 STUDY/NIRAVATH/PRO00021210)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Discharge Nursing Orders
☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☐	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Nursing Orders
◯	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Verify patient has taken SOC (per investigator's choice) oral Capecitabine 1250 mg/m2 OR oral Lapatinib 1250 mg and Capecitabine 1000 mg/m2 appropriately
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Pre-Medications
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	PRN	Start: S				  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	PRN	Start: S					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 21	Perform every 1 day x1		Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
40-Day Follow Up	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	40-day follow up to be scheduled AFTER last study treatment administration or prior to new anticancer treatment. If EOT is GREATER than 40 days after last treatment, then the EOT assessments do not need repeated at this visit.
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
					
Long Term Follow Up	Repeat 6 times	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Long term follow up is to be repeated every 3 months (+/-14 days until death/withdraw consent/study closure/or loss to follow-up). Please schedule patient accordingly.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Complete Survivor Follow-up Documentation: Record new or current anticancer treatments, outcomes, and survival
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)