The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspiration (rpFNA), of breast duct cells.~A stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).~Additional objectives of the study are to:~Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin~Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.~Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:~Ki-67 (a marker of cell proliferation)~Estrogen receptor (ER)~Progesterone receptor (PR)~HER/2-neu over-expression~Susceptibility to DNA damage
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.