There is laboratory evidence that cholesterol lowering medications (statins) inhibit the growth of breast cancer cells. Clinical studies are controversial but some show that women taking statins are less likely to get breast cancer. This ongoing randomized trial compares one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
Atorvastatin, 40 mg daily for 1 year
sugar pill daily for 1 year
University of California, San Francisco
San Francisco, California, United States
RECRUITINGDelaware Christiana Care CCOP, Helen F. Graham Cancer Center
Newark, Delaware, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer.
Time frame: 1 year
To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer.
Time frame: 1 year
To correlate changes in breast density with changes in molecular markers.
Time frame: 1 year
To explore changes in breast duct cell cytology in a subset of patients after 12 months of statin administration in a subset of the trial population.
Time frame: 1 year
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Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGSoutheastern Medical Oncology Center
Goldsboro, North Carolina, United States
RECRUITINGVermont Cancer Center
Burlington, Vermont, United States
RECRUITING