Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women with early-stage breast cancer may help plan treatment.

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer and Leukemia Group B
• Collaborator: National Cancer Institute (NCI)
• Treatments: Metformin

Criteria

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