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

NCT ID: NCT01666171

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 458 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin hydrochloride (metformin) or placebo treatment through one year of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).

Secondary

• To evaluate the change in percent breast density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through two years of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).
• To evaluate whether baseline mammographic density correlates with baseline of fasting plasma insulin, glucose levels, and Homeostasis Model Assessment (HOMA) (collected on the treatment protocol CAN-NCIC-MA.32) (MA.32).
• To evaluate whether changes in dense area in response to metformin therapy from pre-treatment through two years of therapy correlate with changes in fasting plasma insulin, glucose levels, and HOMA (collected on the treatment protocol MA.32) over the same time period.
• To explore whether change in mammographic density for women on metformin is associated with risk of second primary breast cancer.

OUTLINE: Patients' mammograms taken at baseline and at approximately 1 and 2 years of metformin or placebo treatment are retrieved and analyzed for breast-density change. Pre-menopausal patients' menstrual cycle information is also collected at baseline and every 6 months for 2 years.

Conditions

Breast Cancer

Interventions

metformin hydrochloride

Intervention Type: DRUG

clinical observation

Intervention Type: OTHER

diagnostic laboratory biomarker analysis

Intervention Type: OTHER

imaging biomarker analysis

Intervention Type: OTHER

medical chart review

Intervention Type: OTHER

digital mammography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: lead

Responsible Party

Cancer and Leukemia Group B

Principal Investigators

Marie E. Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Other Identifiers

CDR0000738328

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-A211201

Identifier Type: -

Identifier Source: org_study_id