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OP RSH PRO00043125 NIRAVATH A012303 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00043125 NIRAVATH A012303 ARM 1

Screening ( -90 to -1 Day)	Repeat 1 time	Cycle length: 90 days	90 Days Prior to Registration	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink: A012303_Niravath
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for TRASTUZUMAB(+/- PERTUZUMAB Treatment: Refer to Section 8.2 Protocol Access Hyperlink: A012303_Niravath
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	<90 days prior to registration, then every 90 days (+/- 21 days) during HER2-directed therapy. The final ECHO should be performed after the final dose of adjuvant HER2-directed therapy (still at 90 days [+/- 21 days] from the prior ECHO
					
Screening ( -28 to -1 Day)	Repeat 1 time	Cycle length: 28 days	28 Days Prior to Registration	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink: A012303_Niravath
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for TRASTUZUMAB(+/- PERTUZUMAB Treatment: Refer to Section 8.2 Protocol Access Hyperlink: A012303_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History & Physical. <=28 days prior to registration
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Weight. Weight may be checked at an interval determined by local institutional standards, and weight is not required if a patient is receiving nonweight-based therapy (SC formulations of trastuzumab and pertuzumab are not weight-based dosing).
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG PS. ECOG PS to be collected at baseline only
			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. Pregnancy assessment should be performed per standard clinical practice
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. Pregnancy assessment should be performed per standard clinical practice
			Imaging
◉	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies
		◯	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Diagnostic Slides or Images. Only patients consented to Biobanking, within 28 days of registration
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor Tissue. Only patients consented to Biobanking, within 28 days of registration