NCIC MA.32 Eligibility Worksheet A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer NCT01101438 Source Form: NCI FormBuilder:

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August 4, 2015

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Creative Commons BY-NC 3.0 Legacy
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Eligibility Breast Cancer early stage NCIC MA.32 NCT01101438

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  1. StudyEvent: NCIC MA.32 Eligibility Worksheet
    1. No Instruction available.
Header Module
Method of Payment
Patient Characteristics
Patient Race
Patient Ethnicity
Eligibility Criteria
Subject has histologically confirmed invasive breast cancer that has been diagnosed and completely resected within 12 months prior to randomization
Tumor Laterality
Histologic Type
Most extensive definitive surgery
Is invasive cancer at margin?
Is DCIS present? (at resection margin)
Has the subject received adjuvant radiotherapy
Was a boost given? (to the site of residual ductal in situ disease)
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
T Stage, Clinical
N Stage, Clinical
M Stage, Clinical
Subject's TNM Stage (AJCC Version 6) is one of pT1, pT2, pT3; pN0, pN1, pN2, pN3; M0 and subject has one of the pT pN combinations described in protocol section 5.1.4 and subject has sentinel node biopsy and/or full axillary lymph node dissection
Pathologic T Stage
Pathologic N Stage
Pathologic M Stage
Histologic Grade
Is there lymphovascular invasion?
Was sentinel node sampling performed
Was axillary dissection performed?
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
Prior Adjuvant Chemotherapy
Estrogen/progesterone receptor status is known
Receptor Status, ER
Receptor Status, PgR
HER2 status is known
HER-2/neu status
HER2 test type
Subject has had a bilateral mammogram within 12 months prior to randomization
Subject has ECOG Performance Status of 0, 1 or 2
ECOG Performance Status
Subject is < 75 years of age and has life expectancy of at least 5 years
Subject is accessible for treatment and follow-up
Protocol treatment will begin within 10 working days after randomization
Most recent REB approved informed consent has been signed according to local institutional requirements
Most recent REB approved Tissue and Blood Collection and Banking informed consent has been signed and dated by the patient and appropriate "I agree/I don't agree" box has been checked
Is the subject English or French speaking
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
Reason questionnaire was not completed
Is the subject English speaking and has s/he already completed the Quality of Life questionnaire
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
Investigations, including chest X-ray or CT chest, bone scan and abdominal have been performed no earlier than 4 weeks prior to primary surgery and no later than the date of randomization and are negative for metastases
Eligibility Labs
Ineligibility Criteria
Pregnancy Test Result
Physical Exam
Menopausal Status
Hormonal status
Body Mass Index
Has this subject given written consent to participate in MA.32F
Has informed consent been signed and dated by patient and person conducting consent form discussion
Consent form language

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