Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

INCLUSION CRITERIA

   - Female

   - Increased inherited risk of breast cancer, as defined by:

      - Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation

      - Family history conveying at least a 2-fold increase in breast cancer risk

   - ECOG performance status 0

   - Normal organ and marrow function, including complete blood count and comprehensive
   metabolic panel within normal institutional limits

   - Subject agreement to limit alcoholic beverage consumption to three alcoholic drinks
   per week.

EXCLUSION CRITERIA

   - Prior history of invasive breast cancer less than 2 years previously (EXCEPTION: stage
   III or lower breast cancer > 2 years ago)

   - Current or history of other cancers (EXCEPTION: non-melanoma skin cancer, or stage III
   or cancer without evidence of recurrence for 5 years

   - Initial mammogram, breast MRI, or clinical breast examination prompts recommendation
   for biopsy by study investigators.

   - Evidence of malignant cytology on initial rpFNA.

   - Use of other investigational agents.

   - Use of tamoxifen or selective estrogen response modifiers (SERMS), including
   raloxifene, within the last 2 years.

   - History of allergic reactions attributed to compounds of similar chemical or biologic
   composition to lovastatin.

   - Uncontrolled intercurrent illness including, but not limited to, ongoing or active
   infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac
   arrhythmia; or psychiatric illness/social situations that would limit compliance with
   study requirements.

   - Currently receiving lovastatin and cyclosporine, gemfibrozil, erythromycin, fibrates
   or niacin, (unless discontinued for study participation)

   - No evidence of active liver disease, nor elevation of serum transaminases (prior
   history of liver disease, if not currently active, is not an exclusion)

   - No evidence of myopathy or myositis, including symptoms of generalized muscle aches or
   weakness, muscle tenderness, or elevation in creatine phosphokinase.

   - Lactating (breastfeeding)