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RSH OP PRO00038062 CAMBRIA-2 /SCREENING	

Types:      Research Oncology Treatment
Synonyms:  CAMBRIA-2, SCREENING, BASELINE

Baseline / Screening	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 0 days x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Complete physical examination 

*If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed*
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Determine and record ECOG performance status
ECOG Performance status:** date:**
			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior to randomisation: Full body bone imaging, abdominal +/- pelvic imaging, and chest imaging must be performed within 12 months prior to randomisation. Bone imaging, abdominal +/- pelvic imaging, and chest imaging performed previously as part of routine care, any time in the process of or after diagnosing the patient with the current breast cancer diagnosis, may be used as the baseline assessment. 
Post randomisation: Performed locally and only if clinically indicated per investigator's judgement. 

If PET/CT is performed, additional imaging modalities are not required.
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	PET CT WHOLE BODY	Interval: --	Occurrences: --		  	NM SPECT BONE SCAN	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Breast imaging
Breast imaging required (MRI OR mammogram): 
Prior to randomization: Patients must have breast imaging performed locally prior to surgery or within 9 months prior to randomization. 
Post-randomization: The assessments will be performed either at yearly intervals, as recommended per international standard guidelines, or according to local standards as part of routine medical care. Patients who have had a mastectomy should be followed per local practice.
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Single 12-lead ECGs will be performed after the patient has been resting semi-supine for at least 5 minutes and recorded while the patient remains in that position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. Refer to Table 7 for QTc withdrawal criteria and any additional QTcF readings that may be necessary.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	For women of childbearing potential, a negative result from serum pregnancy test must be available at the screening visit, and serum or urine beta-HCG pregnancy test should be performed as clinically indicated during treatment. Pregnancy tests can be performed at any other time during study treatment in accordance with local clinical practice.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Follicle-stimulating hormone and estradiol testing may be required for female patients in screening for determining menopausal status.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Clinical chemistry and hematology at screening may be re-tested once within the 28-day screening period. This re-test will not be considered rescreening and is allowed. If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1
Day 1 if the patient's condition has not changed
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Procedures
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Confirm Ki-67 assessed based on tumor sample. Mandatory samples should be sent during the screening period.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Ki67

All patients will have Ki67 assessed prospectively using archival, treatment-naïve tumor sample (collected during diagnostic workup or resected sample).
Mandatory samples should be sent during the screening period. Ki67 will be assessed centrally via an AstraZeneca-provided laboratory test when permissible by local regulations. Site monitor/CRA should be contacted for questions about whether local health authorities require specific in vitro diagnostic approvals and the status of those approvals. For a specific subset of patients who do not have any other risk factors, the result should be received prior to randomization in order to assess eligibility or for stratification purposes.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory archival screening tumor sample.
Screening period: day -28 to -1	
(Collected during diagnostic workup or resected sample) This sample or its derivatives may be used to develop current or future diagnostics for breast cancer. Collection of these samples will only be done where locally applicable/permissible.