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OP RSH PRO00037694 ALLIANCE A012103 - JAIN SCREENING	

Types:      Research Oncology Treatment
Synonyms:  A012103, TNBC, CHECK POINT INHIBITOR, ALLIANCE, PRO00037694

Screening/Baseline	Repeat 1 time	Cycle length: 28 days	28 days prior to Registration	Perform every 1 day x1			Research tolerance: -7/+7 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:   A012103 - Jain
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment : Refer to Section 8.1
Protocol Access Hyperlink:  A012103 - Jain
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and physical

28 days Prior to registration
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG PS

28 days Prior to registration. 
 
To be collected at baseline only.
			Nursing Orders
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Solicited Medical History - Immune-Related Adverse Events 

Prior immune (pembrolizumab)-related adverse events (irAEs) are to be entered in the "Medical History: Solicited Conditions" CRF in Medidata Rave. Solicited irAEs include myocarditis, colitis, pneumonitis, dermatitis radiation, rash maculo-papular, adrenal insufficiency, hypothyroidism, and peripheral sensory neuropathy
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - CTCAE 

28 days Prior to registration
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - PRO-CTCAE 

28 days Prior to registration

Optional. Please refer to the CTSU website for PRO-CTCAE items.
			Imaging
◉	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	28 days Prior to registration 

Patients must have had a mammogram, breast ultrasound or MRI within one year prior to registration.
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	28 days Prior to registration 

Patients must have had a mammogram, breast ultrasound or MRI within one year prior to registration.
		◯	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --	Comments:	28 days Prior to registration 

Patients must have had a mammogram, breast ultrasound or MRI within one year prior to registration.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	QOL/Value of Care 

Prior to registration

Correlative studies: For patients who consent to participate. FACT-B , WPAI:SHP,FACIT-COST, CoPaQ
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Health Care Utilization CRFs 

Prior to registration
				Within 7 days of registration	Perform every 1 day x1			Research tolerance: -3/+3 days	Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs completed prior to registration may be used for day 1 of cycle 1 tests if obtained LESS THAN or EQUAL to 14 days prior to treatment.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs completed prior to registration may be used for day 1 of cycle 1 tests if obtained LESS THAN or EQUAL to 14 days prior to treatment.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --	Comments:	Labs completed prior to registration may be used for day 1 of cycle 1 tests if obtained LESS THAN or EQUAL to 14 days prior to treatment.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Less than or equal to  7 days prior to registration.
For women of childbearing potential (see Section 3.2.5).
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Less than or equal to  7 days prior to registration.
For women of childbearing potential (see Section 3.2.5).
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Less than or equal to  7 days prior to registration.
For women of childbearing potential (see Section 3.2.5).
			Nursing Orders
  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Within 7 days after registration 

Whole blood in EDTA tubes, Tissue and optional biobanking