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Protocol No. A211102

Principal Investigator Wilke, Lee

Phase III (Cancer Prevention)

Age Group Adult

Scope National

Sponsor Type National

Title Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women

Objective The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. We would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better.

Treatment If the exams, tests and procedures show that you can be in the study, you will be registered and "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance (as in the flip of a coin). You will have an equal chance of being placed in either group. Group I will receive metformin tablets. Group 2 will receive placebo tablets, which are not active (like a sugar pill).

Description When you start the study treatment, you will take 1 metformin/placebo pill every day for the first 4 weeks (called the "ramp-up period"). After this, you will take one pill by mouth two times a day - one pill in the morning and one in the evening. After 12 months of treatment, you will be told by your clinic staff whether you were receiving metformin or the placebo. Click here for more info

Key Eligibility
  • Must be at increased risk for breast cancer, defined as at least one of the following four criteria: a prior biopsy demonstrating atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ, a Gail Model Risk of 1.66% or greater over 5 years, a strong family history of breast and/or ovarian cancer, or known BRCA1 or BRAC2 mutation carrier.
  • Age 25 - 55 years
  • Pre-menopausal
  • If eligible to take tamoxifen must be offered tamoxifen prevention as part of their clinical care and have refused tamoxifen

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics