A Phase II Trial of Lovastatin for Modification of Abnormal Breast Duct Cytology and Risk-Associated Biomarkers in Women at High Inherited Risk of Breast Cancer
The purpose of the study is to determine whether oral lovastatin, used for 6 months, results in a decrease of abnormal breast duct cytology in women at high inherited breast cancer risk.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Lovastatin
Phase: Phase 2
Ages Eligible For Study:
- Women with an increased inherited risk of breast cancer, but no current breast cancer. Defined by either: - Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation - Family history conveying at least a 2-fold increase in breast cancer risk - Only those patients without evidence of abnormality requiring biopsy on mammography, breast MRI, or clinical breast examination will be eligible for inclusion. - Patients must have ECOG performance status 0. - Patients must have normal organ and marrow function, including complete blood count and comprehensive metabolic panel within normal institutional limits. - Patients must have no evidence of active liver disease, or elevation of serum transaminases. Prior history of liver disease, if not currently active, will not exclude patients from participation. Patients must have no evidence of myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase. In order to be eligible for participation, patients will be asked to limit alcoholic beverage consumption to three alcoholic drinks per week. This is specified because of recommendations for caution with use of lovastatin in patients with heavy alcohol use. - Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Only women who are not currently breastfeeding will be eligible to participate.