Protocol Index	

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OP RESEARCH PRO00040327 / NAIR A012301 PHASE III PRIOR TO REGISTRATION	

Types:      Research Oncology Treatment
Synonyms:  LOTAM, SOLTAMOX, FEMARA, ARIMIDEX, AROMASIN

Prior to Registration	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Nursing: Protocol Hyperlink: 
-  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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Laboratory and clinical parameters during treatment are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	History and Physical to be completed less than or equal to 60 days before registration.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Breast Exam
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Performance Status
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Breast Imaging (Mammogram or MRI)
-  Required only in patients with at least one intact breast, patients with bilateral mastectomy do not require imaging. 
-  The first surveillance breast imaging will be obtained 12 ± 3 months after the most recent imaging completed prior to registration and then every 12 ± 3 months thereafter (LESS than or EQUAL 6 months before registration). 
-  Breast imaging may be performed more frequently at the discretion of the investigator.
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST BILATERAL LIMITED	Interval: --	Occurrences: --		  	MRI BREAST BIOPSY BILATERAL	Interval: --	Occurrences: --		  	MAMMO BREAST SCREEN TOMOSYNTHESIS LEFT	Interval: --	Occurrences: --		  	MAMMO BREAST SCREEN TOMOSYNTHESIS RIGHT	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --	Comments:	DEXA bone density monitoring is not mandated, but is recommended at least within 1 year of beginning protocol-directed therapy and after year 3.
			Procedures
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	-  Submission of FFPE tissue from the primary breast tumor surgical specimen within 90 days following registration. 
-  In patients who have received up to 6 weeks of preoperative endocrine therapy submit FFPE tissue from both the biopsy specimen and the surgical specimen.