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Changes in Breast Density in Patients with Early-Stage Breast Cancer Treated with Metformin Hydrochloride or Placebo on NCIC-MA.32
Trial Status: closed to accrual
This clinical trial studies changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on National Cancer Institute of Canada (NCIC)-MA.32. Learning about the effect of metformin hydrochloride in breast density of women with early-stage breast cancer may help plan treatment.
Inclusion Criteria
Patients must either be concurrently enrolling or previously enrolled to NCIC study MA.32; eligible patients may be either pre- or post-menopausal
Patients must have hormone receptor-negative breast cancer
Patients must have baseline breast density measurement as defined by one of the following:
* >= 25% breast density, or
* Scattered fibroglandular densities, or
* Breast Imaging-Reporting and Data (BIRAD)-2 or greater density category (not BIRAD clinical interpretation)
Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to NCIC 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 and breast density measurement must also be available for submission
Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible
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
Patients previously enrolled to NCIC Clinical Trials Group (CTG) MA.32 must have taken metformin/placebo at least until the date of the 1-year mammogram used for this study and must not have experienced recurrence by that date
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01666171.
Locations matching your search criteria
United States
Kansas
Prairie Village
Kansas City NCI Community Oncology Research Program
I. To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin (metformin hydrochloride) or placebo treatment through one year of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).
SECONDARY OBJECTIVES:
I. 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).
II. 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 MA.32 [NCIC-MA.32]).
III. 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.
IV. 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.
Trial PhasePhase II
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationAlliance for Clinical Trials in Oncology
