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This study looks at the role of simvastatin, a cholesterol-lowering drug, in preventing a new breast cancer in women who are at high risk for one. Women with a history of breast cancer and at least one healthy intact breast were able to take part. Sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, the study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * History of histologically confirmed breast cancer, meeting 1 of the following staging criteria: * Ductal carcinoma in situ * Stage I-III invasive breast cancer * At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy * May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed ≥ 3 months ago * At least 1 healthy intact breast * No prior radiotherapy or mastectomy * Prior biopsies allowed * Any hormone-receptor status PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No active liver disease * AST and ALT ≤ 3 times upper limit of normal * Creatinine clearance ≥ 30 mL/min * No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components * No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No daily alcohol use \> 3 standard drinks per day * Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor * No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months * No hormone replacement therapy (HRT) within the past 3 months * No prior estrogen and/or progesterone HRT ≥ 5 years in duration * Vaginal estrogen preparations allowed * No concurrent HRT * No other cholesterol-lowering drug, including a statin, within the past 3 months * No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil * No concurrent daily grapefruit juice consumption \> 8 ounces per day * No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer