Trial Search Results

Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Lovastatin

Phase:

Phase 2

Eligibility


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)

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Meredith Mills
6507245223
Not Recruiting