Protocol Index	

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OP RESEARCH PRO00036449 / RAMSHESH NRG-BR007 PHASE III SCREENING	

Types:      Research Oncology Treatment
Synonyms:  RADIATION, STAGE I, HORMONE, ONCOTYPE, DEBRA

Take-Home Medications	Repeat 1 time	Cycle length: 1 day	Day -1	Perform every 1 day x1		Medications
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for ENDOCRINE THERAPY - Refer to Institutional guidelines for each drug:  Tamoxifen, Anastrozole, Letrozole, Exemestane.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.  
- Tamoxifen 20mg Daily
- Anastrozole 1mg Daily
- Letrozole 2.5mg Daily
- Exemestane 25mg Daily
			Take-Home Medications Prior to Treatment
  	tamoxifen (NOLVADEX) 20 MG chemo tablet	Dose: 20 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	anastrozole (ARIMIDEX) 1 mg chemo tablet	Dose: 1 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	letrozole (FEMARA) 2.5 mg chemo tablet	Dose: 2.5 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S				  	exemestane (AROMASIN) 25 mg chemo tablet	Dose: 25 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 11	Start: S							
Screening	Repeat 1 time	Cycle length: 90 days	Within 12 Weeks of Study Entry	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Confirm Oncotype DX Recurrence Score LESS than or EQUAL 18 - Per NCCN 2019 guidelines, an Oncotype DX RS is indicated for breast cancers greater than 0.5 cm in size and this can be ordered by any of the patient's providers including surgeon, medical oncologist, and radiation oncologist. For patients with T1a (LESS than or EQUAL 0.5 cm in size) tumors who do not have a RS and are otherwise eligible, a tissue sample will be sent to Genomic Health for determining the Oncotype DX RS. Patients with an Oncotype DX RS LESS than 18 are eligible for enrollment.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Determination of hormone receptor status
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Determination of HER2 status
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Menopausal status - Menopausal status at the time of breast cancer diagnosis.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Health-Related Quality of Life (HRQOL) questionnaire - For patients who agree to participate in the HRQOL study, the HRQOL questionnaire must be administered after the informed consent is signed but before study entry.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	History and Physical Exam - Complete H&P by physician or other healthcare professional.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Collection and submission of optional blood specimen - Before or after randomization (before therapy begins).  Requirement for all patients who agreed to optional blood collection and submission in the consent form.
			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Bilateral breast imaging (Mammogram or MRI) - Within 6 months of randomization.  Ultrasound is not a permissible substitute for either a mammogram or MRI.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Staging imaging - Staging imaging is not required but if performed as part of clinical care must not show any definitive radiologic evidence of metastatic disease. Imaging studies should be performed if clinically indicated at the investigator's discretion.
			Medications
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for ENDOCRINE THERAPY - Refer to Institutional guidelines for each drug:  Tamoxifen, Anastrozole, Letrozole, Exemestane.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.  
- Tamoxifen 20mg Daily
- Anastrozole 1mg Daily
- Letrozole 2.5mg Daily
- Exemestane 25mg Daily
				Within 2 Weeks of Randomization	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Central testing for Oncotype DX Recurrence Score for patients with T1a tumors (LESS than or EQUAL 0.5 cm in size) without a Recurrence Score - After study entry but before randomization.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential - Pregnancy testing must be performed according to institutional standards.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential - Pregnancy testing must be performed according to institutional standards.