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

NCT01666171 | Unknown

• 2 other identifiers: CALGB-A211201CDR0000738328
• Study Type: observational
• Target: 458
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 1 year using two-sample t-test or Wilcoxon rank-sum test

Secondary Outcomes (4)

• Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 2 years using two-sample t-test

• Correlation between baseline mammographic density and baseline plasma fasting insulin, glucose levels, and HOMA using a scatter plot, correlation-coefficient estimation, and linear-regression method

• Correlation of changes in dense area in response to metformin therapy from pre-treatment to on treatment (at year 1 and year 2) with plasma fasting insulin, glucose levels, and HOMA using simple linear-regression method

• Correlation between mammographic density and the incidence of second primary breast cancer using correlation coefficient and scatter plot

Interventions

metformin hydrochloride DRUG

clinical observation OTHER

diagnostic laboratory biomarker analysis OTHER

imaging biomarker analysis OTHER

medical chart review OTHER

digital mammography PROCEDURE

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer and Leukemia Group B: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin; Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Marie E. Wood, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-01