Status:
TERMINATED
Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
Lead Sponsor:
Stanford University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 du...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00285857
Start Date
November 1 2005
End Date
December 1 2010
Last Update
March 9 2017
Active Locations (1)
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1
Stanford University Cancer Center
Stanford, California, United States, 94305