Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Dihydromevinolin; L 647318; Lovastatin

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)