Enrollment complete
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
NCT No.: NCT01666171
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym:
Official Title
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
Purpose
PURPOSE: This trial studies changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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DISEASE CHARACTERISTICS:
• Patients must either be concurrently enrolling or previously enrolled to Canada (CAN) National Cancer Institute of Canada (NCIC) study MA.32 (CAN-NCIC-MA.32) (MA.32); eligible patients may be either pre- or post-menopausal
• Patients must have hormone receptor-negative breast cancer
• Patients must have breast density ≥ 25% (correlating with the Breast Imaging-Reporting and Data [BIRAD]-2 category of "scattered fibroglandular densities" or greater)
• Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to MA.32 must be available for submission; if the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission
• Contralateral unaffected breast in place (with no prior cancer or radiation, no implants, and no plan for breast surgery on contralateral breast over the course of the study); women with a prior biopsy on the unaffected breast are eligible
PATIENT CHARACTERISTICS:
• Not specified
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible
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Exclusion Criteria
Keywords and/or Specific Medical Conditions
- Obstetrics and Gynecology
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Sponsors
- Cancer and Leukemia Group B
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