Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Lovastatin
Intervention description: Lovastatin 80 mg/day as 40 mg orally twice daily.
Lovastatin is approved by FDA as a cholesterol-lowering agent.
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: duct cytology

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.
    

Eligibility criteria:

        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)