Protocol Index	

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RESEARCH PRO18449 PATEL SWOG S1418 / BR006 ARM 1: OBSERVATION	

Types:      Research Oncology Treatment
Synonyms:  18449, BREAST CANCER , PRO00018449

Pre-study Screening: (Step 1)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Slides must be submitted as described in Section 15.1. Patients cannot be randomized to Step 2 until email confirmation has been received indicating that the specimen was adequate for determining PD-L1 status.
					
Randomization (Step 2)	Repeat 1 time	Cycle length: 10 days	Day 1	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 1	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
					
Cycle 2	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycles 3,4	Repeat 2 times	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Cycle 5	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
End of Year Assessment	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Follow Up 6 Months (Month 18 from Randomization)	Repeat 1 time	Cycle length: 182 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 24-54 follow up (every 6 months follow-up)	Repeat 6 times	Cycle length: 182 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Month 60 follow up	Repeat 1 time	Cycle length: 365 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Year 6 -10 (Follow-Up every 1 year) 	Repeat 5 times	Cycle length: 365 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Complete physical exam.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood Pressure, heart rate, respiratory rate, and oral temperature.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Calculate body surface area (BSA).
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	ECOG Performance status.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --