Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer

You may be eligible if

• 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