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OP RSH PRO00045409 J2J-MC-JZLL MAI COHORT 2	

Types:      Research Oncology Treatment
Synonyms:  PRO00045409 J2J-MC-JZLL MAI, J2J-MC-JZLL MAI

Cycle 1	Repeat 1 time	Cycle length: 180 days	Start of Treatment - Day 1	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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Tamoxifen will be dispensed by IDS pharmacy via paper prescription
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Imlunestrant will be dispensed by IDS pharmacy via paper prescription
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	- Notify provider if: QTcF GREATER than 500 msec or there is increase in QTc GREATER THAN 60 msec from baseline, confirmed by at least 2 consecutive readings
- Notify provider if: AST / ALT are GREATER than 3x ULN
- Notify provider if: Total Bilirubin is GREATER than or EQUAL to 2x ULN
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Coagulation. AS CLINICALLY INDICATED
		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Menstrual cycle information
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood germline genetic sample. May be collected prior to Visit 1 or on Visit 1 . Sample may be collected anytime if not collected on Visit 1 .
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones
				On Treatment - Day 30	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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Tamoxifen will be dispensed by IDS pharmacy via paper prescription
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Imlunestrant will be dispensed by IDS pharmacy via paper prescription
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Coagulation. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	- Notify provider if: QTcF GREATER than 500 msec or there is increase in QTc GREATER THAN 60 msec from baseline, confirmed by at least 2 consecutive readings
- Notify provider if: AST / ALT are GREATER than 3x ULN
- Notify provider if: Total Bilirubin is GREATER than or EQUAL to 2x ULN
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Menstrual cycle information
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones
				On Treatment - Day 90	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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Tamoxifen will be dispensed by IDS pharmacy via paper prescription
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Imlunestrant will be dispensed by IDS pharmacy via paper prescription
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Coagulation. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	- Notify provider if: QTcF GREATER than 500 msec or there is increase in QTc GREATER THAN 60 msec from baseline, confirmed by at least 2 consecutive readings
- Notify provider if: AST / ALT are GREATER than 3x ULN
- Notify provider if: Total Bilirubin is GREATER than or EQUAL to 2x ULN
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Menstrual cycle information
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
			Imaging
  	US PELVIC TRANSVAGINAL	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones
				End of Treatment - Day 180	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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Tamoxifen will be dispensed by IDS pharmacy via paper prescription
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Imlunestrant will be dispensed by IDS pharmacy via paper prescription
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Coagulation. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	- Notify provider if: QTcF GREATER than 500 msec or there is increase in QTc GREATER THAN 60 msec from baseline, confirmed by at least 2 consecutive readings
- Notify provider if: AST / ALT are GREATER than 3x ULN
- Notify provider if: Total Bilirubin is GREATER than or EQUAL to 2x ULN
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Menstrual cycle information
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
			Imaging
  	US PELVIC TRANSVAGINAL	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones
					
Post - Treatment (Short- Term Follow - Up)	Repeat 1 time	Cycle length: 1 day	Day 1	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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Coagulation. AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Disease recurrence assessment
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
			Imaging
  	US PELVIC TRANSVAGINAL	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones