Breast Cancer Clinical Trial
Official title:
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
Verified date | January 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 458 |
Est. completion date | |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 74 Years |
Eligibility |
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 |
N/A
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cancer and Leukemia Group B | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | ||
Secondary | Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 2 years using two-sample t-test | No | ||
Secondary | 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 | No | ||
Secondary | 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 | No | ||
Secondary | Correlation between mammographic density and the incidence of second primary breast cancer using correlation coefficient and scatter plot | No |
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