A Double Blind Prospective Study of Metformin vs. Placebo in Overweight or Obese Post-menopausal Women at Elevated Risk for Breast Cancer
PRIMARY OBJECTIVES:
I. To determine the changes in the signal pathway profiling of breast tissue using reverse
phase proteomics in tissue biopsy of overweight or obese women at elevated risk for breast
cancer treated with metformin (metformin hydrochloride) (850mg orally twice a day) for 12
cycles.
SECONDARY OBJECTIVES:
I. To determine the effect of metformin on breast tissue density of overweight or obese
women at elevated risk for breast cancer using qualitative mammographic fat density
criteria.
II. To determine the effect of metformin on the insulin axis in serum of overweight or obese
women at elevated risk for breast cancer treated with metformin (850mg orally twice a day)
for 12 cycles.
III. To determine the toxicities associated with metformin.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive metformin hydrochloride by mouth once daily on days 1-30 in course 1
and twice daily on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in
the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo by mouth once daily on days 1-30 in course 1 and twice
daily on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 5
years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Changes in the phosphorylation of proteins after metformin exposure
Reverse phase proteomic assays (RPPA) will be performed to measure changes in the phosphorylation of proteins after metformin exposure. Changes in the phosphorylation of proteins after metformin exposure will be calculated and compared using two-sample t-tests. As a supplemental analysis, analysis of covariance (ANCOVA) will be used to model the 12 month levels adjusted for baseline. Assumptions for analysis will be checked and non-parametric methods used if needed; however it is expected that the data will be normally distributed on the log scale.
Baseline and 12 months
No
Lida Mina
Principal Investigator
Indiana University Melvin and Bren Simon Cancer Center
United States: Institutional Review Board
IUCRO-0365
NCT01793948
April 2013
Name | Location |
---|---|
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |