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Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
Trial ID: NCT00285857
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.
A Phase 2 Trial of Lovastatin for Modification of Abnormal Breast Duct Cytology and Risk-Associated Biomarkers in Women at High Inherited Risk of Breast Cancer
- 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
- 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
- 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)
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