NCT00914017

Statins and Breast Cancer Biomarkers

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Atorvastatin	Atorvastatin, 40 mg daily for 1 year
DRUG	Placebo	sugar pill daily for 1 year

Timeline

• Start date: 2005-01-01
• Primary completion: 2010-12-01
• First posted: 2009-06-04
• Last updated: 2010-02-11

Locations

7 sites across 1 country: United States