Conditions: Breast Cancer
Keywords: duct cytology
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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

Arms:
arm 1: Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.

Interventions: intervention 1: Lovastatin
Intervention descriptions: intervention 1: Lovastatin 80 mg/day as 40 mg orally twice daily.

Lovastatin is approved by FDA as a cholesterol-lowering agent.

Protocol document: