Protocol Index	

If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

RSH OP PRO00036788/CAMBRIA-1 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  CAMBRIA-1, SCREENING, BASELINE

Baseline / Screening( 28 Days Prior to C1D1 )	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 0 days x1		Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --	Comments:	Informed consent: Main Study.
-- Written informed consent and any locally required privacy act document authorization must be obtained prior to performing any protocol-specific procedures, including screening/baseline evaluations
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical examination  --
Physical examinations should be performed according to institutional standards (see Section 8.2.1 for details).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical history (past and current medical conditions) ..
---Should include baseline tumor characteristics, prior and concomitant medication, as well as oncological history (including BRCA status), previous cancer
therapy, and lifestyle considerations
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Ocular assessment -- 
Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular
assessments should be performed in both treatment arms.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	AE reporting --
Adverse events (AEs)/serious AEs (SAEs) must be reported for all enrolled patients from the date of signing the ICF through the Safety Follow-up Period
(28 days [+7 days] post EOT) (see Section 8.3.1). During the screening period, only SAEs related to any study mandated procedures, not routinely performed procedures must be reported to AstraZeneca.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient-reported Outcomes --

Prepare ePRO device 
(at least 24 hours prior to Month 1 Day 1)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Imaging of abdomen (± pelvis), chest, and bone must be performed prior to randomization. If done previously as part of routine standard of care, it may be used as baseline assessment provided that it is performed within 12 weeks of randomization. Additional symptom-directed scanning (such as brain imaging) may be performed if there is a suspicion of metastatic disease
		  	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:	If a patient with conservative surgery has not had a bilateral mammogram or breast MRI within 9 months prior to randomization, then this assessment must
be performed prior to randomization. Radiological examinations in male breast cancer patients as well as ipsilateral radiological examination in female
patients undergoing mastectomy will be replaced by clinical examination and local chest wall ultrasound as required. 
T
		  	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. Electrocardiograms at screening may be re-tested once within the 28-day screening period. This re-test will not be
considered rescreening and is allowed. Any clinically significant abnormalities detected require triplicate ECG results (see Section 8.2.3).
			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 (test must have sensitivity of at least 25 mIU/mL) must be available at
the screening visit, and serum or urine ß-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 or if required by local regulations.
		  	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
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of the tumor sample for Ki-67 central assessment is mandatory at screening only when it is needed for confirmation of eligibility or for
stratification into high or intermediate risk. For patients for whom the Ki-67 result is not needed to confirm eligibility or to properly stratify the patient,
this sample can be provided after randomization
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory archival screening tumor sample. **day -28 to -1	(collected during diagnostic workup or resected sample) . On approval from AstraZeneca to send samples, a mandatory archival tumor sample should be requested during screening but does not have to be received prior to randomization. This sample or its derivatives may be used to develop current or future
diagnostics for breast cancer
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis