Phase II Trial - Breast Cancer Chemoprevention by Lovastatin

The purpose of the study is to determine whether oral lovastatin, given daily at a dose of
80 mg for six months, results in a decrease in the rate of abnormal breast duct cytology
(either hyperplasia or hyperplasia with atypia as measured by random periareolar fine needle
aspiration (rpFNA) of breast duct cells) in women at high inherited breast cancer risk. 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

- To assess incidence of breast cancers and new high-risk breast lesions, including
atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.

- To 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