Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
18 Years
74 Years
Female
Breast Cancer
Trial Information
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
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.
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Marie E. Wood, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Vermont
Authority:
Unspecified
Study ID:
CDR0000738328
NCT ID:
NCT01666171
Start Date:
August 2012
Completion Date:
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
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