Statins and Breast Cancer Biomarkers
This project was designed to evaluate the effect of a specific statin (atorvastatin) on
several breast cancer biomarkers. One hundred women will be treated for one year with either
40 mg of atorvastatin or placebo. The primary aim of this project is to determine the effect
of atorvastatin on breast density, a known risk factor for breast cancer. In addition, the
affect of atorvastatin on serum biomarkers (IGF1) and tissue biomarkers (atypia and Ki67)
associated with risk is being evaluated.
Because of their tolerability and safety, statins have a great potential as a breast cancer
preventative agent. Should this pilot study show a significant decrease in breast density
and/or change in serum and tissue biomarkers in statin treated patients these data would
then be used to support a large randomized trial.
This is a multi-center, prospective, randomized placebo controlled clinical trial. Target
enrollment is 100 women, with 50 receiving atorvastatin and 50 receiving a similar appearing
placebo tablet. Eligible women must be at least 35 years old with regular menstrual cycles
and a Gail Model risk of greater than 1.66% over 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer.
Marie E Wood, MD
University of Vermont
United States: Institutional Review Board
|Vermont Cancer Center||Burlington, Vermont 05401-3498|
|Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|Southeastern Medical Oncology Center||Goldsboro, North Carolina 27534|
|University of California, San Francisco||San Francisco, California 94143|
|Duke University||Durham, North Carolina 27710|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Delaware Christiana Care CCOP, Helen F. Graham Cancer Center||Newark, Delaware 19718|