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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

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion 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

Exclusion Criteria

N/A

Keywords and/or Specific Medical Conditions

  • Obstetrics and Gynecology
  • Oncology (Adult)

Sponsors

  • Cancer and Leukemia Group B

Clinical Area

  • Obstetrics and Gynecology
  • Oncology (Adult)

Principal Investigator

Tatjana Kolevska  

Contact Information

 - CTP Digital Solutions
- CTP-DigitalSolutions@kp.org
- Central Valley-Manteca

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