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OP RSH PRO00044268 NAIR NRG-BR009 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00044268 NAIR NRG-BR009, OVARIAN FUNCTION SUPPRESSION, PREMENOPAUSAL PATIENTS, ER-POSITIVE/HER2-NEGATIVE BREAST CANCER, ONCOTYPE RECURRENCE SCORE LESS THAN OR EQUAL TO 25 (OFSET)

Baseline/Screening	Repeat 1 time	Cycle length: 364 days	Prior to Entry	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	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:     NRG-BR009_Nair
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management: Refer to Section 6.0 Protocol Access Hyperlink:    NRG-BR009_Nair
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Consent form signed by the patient
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Oncotype DX Recurrence Score LESS THAN 26.(see Section 3.2.12)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Determination of estrogen-receptor status and HER2 status. (Section 3.2.13)
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Menopausal status. (Section 3.2.3) Patients must be pre-menopausal at the time of study entry as defined in Section 3.2.3.
				After pre-entry but before randomization	Perform every 1 day x1			Research tolerance: -0/+0 days	Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	After pre-entry but before randomization.Central testing for Oncotype DX Recurrence Score . (for patients with MammaPrint test result only see Section 3.1)
				Within 16 weeks	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	History & physical exam. Baseline H&P by physician or other healthcare professional.
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Assessment of performance status ECOG
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications assessment
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Pregnancy history
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --				Within 2 weeks	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --				Within 12 months	Perform every 1 day x1			Research tolerance: -0/+0 days	Imaging
◉	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	Within 12 months.Ultrasound is not a permissible substitute for either a mammogram or MRI. For patients who have had a mastectomy, imaging will be unilateral if patient has not had a bilateral mastectomy (with or without reconstruction).
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Within 12 months.Ultrasound is not a permissible substitute for either a mammogram or MRI. For patients who have had a mastectomy, imaging will be unilateral if patient has not had a bilateral mastectomy (with or without reconstruction).
				After informed consent is signed,but before randomization	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health-Related Quality of Life (HRQOL) questionnaire. For patients who agree to participate in the HRQOL study, the questionnaire must be administered after the informed consent is signed but before randomization (see Section 11). The baseline questionnaire will be collected on paper. All other timepoints may be collected electronically using VisionTree Optimal Care (VTOC) as the preferred data collection method; however, if not possible, paper forms can be used for data collection. For instructions on collecting PROs, please refer to Appendix III.
				Before therapy begins	Perform every 1 day x1			Research tolerance: -0/+0 days	Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Before therapy begins. Collection and submission of optional BR009 blood specimens 
Requirement for all patients who agreed to optional blood collection and submission in the consent form. See Section 10 and the NRG-BR009 Pathology and Correlative Science Instructions