A phase II breast cancer chemoprevention study of lovastatin in high-risk women: Initial feasibility data

1502 Background: More than 250,000 U.S. women have high inherited breast cancer risk; many develop hormone-receptor negative (ER/PR-) tumors, for which no chemoprevention exists. Pre-clinical data suggest that hydrophobic HMG-CoA reductase inhibitors (statins) may reduce risk of ER/PR- breast cancers. We report initial feasibility results of a phase II study of lovastatin for breast cancer chemoprevention. Methods: Study Design: Single-arm, non-randomized phase II study. Agent: Lovastatin 80 mg daily for 6 months. Primary Endpoint: Change in proportion of women with atypical cytology on 2-quadrant random periareolar fine needle aspiration (rpFNA) of breast duct cells before and after lovastatin. Secondary Endpoints: Changes in Ki-67, ER/PR, and elevated levels of oxidative DNA damage (ODD) measured by single-cell gel electrophoresis (Comet) assay of breast duct cells; changes in mammographic density; breast cancer incidence. Eligibility: BRCA1/2 mutation carrier, or estimated lifetime risk = 20% due to fa...