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

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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01101438 Pre-Study - NCIC MA.32 Baseline Report - 3027459v1.0

Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

Tobacco Smoking History - Baseline
Has the patient previously been a smoker?
Does the patient currently smoke
Smoking history
Alcohol Consumption - Question
Alcohol Use in the Past Year
Average Alcohol Consumption
Bilateral Breast Carcinoma - Question
Was this subject enrolled as having bilateral breast carcinoma
Bilateral Breast Carcinoma
Pathologic T Stage
Pathologic N Stage
Pathologic M Stage
Was sentinel node sampling performed
Was axillary dissection performed?
Baseline Adverse Events - Question
Did the participant report any symptoms or adverse events?
Baseline Advers Events
AE Ongoing
Cardiovascular History - Question
Has the patient suffered cardiovascular disease?
Cardiovascular History
Problem, cardiovascular
Baseline Concomitant Medications
Did the participant report taking any concomitant medication
Is this medication continuing?
Adjuvant Radiation Therapy
Has the patient received adjuvant RT
Systemic Therapy
Has the patient received systemic therapy?
Therapy Intent
Major Medical Problems At Baseline
Other Clinical Trial Participation
Is the subject participating in another clinical trial of Breast Cancer treatment

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