Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Meets any of the following criteria:
• •* History of invasive breast cancer
• •* History of ductal carcinoma in situ
• •* At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer
• •Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer
• •No active breast cancer with known metastatic involvement
• •Hormone receptor status not specified
• •PATIENT CHARACTERISTICS:
• •Female
• •Postmenopausal
• •ECOG performance status 0-2
• •AST and ALT ≤ 3 times upper limit of normal
• •Creatinine clearance ≥ 30 mL/min
• •No active liver disease
• •No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components
• •No daily alcohol use of \> 3 standard drinks/day
• •* A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No cholesterol-lowering drug, including a statin, within the past 3 months
• •No selective estrogen receptor modulator (SERM) within the past 3 months
• •No other hormone therapy within the past 3 months
• •No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years
• •* Vaginal estrogen preparations allowed
• •No other concurrent statin or cholesterol-lowering drug
• •No other concurrent SERM
• •No other concurrent hormone therapy
• •No other concurrent investigational drugs
• •No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine
• •No concurrent chemotherapy or biological agents
• •No concurrent daily grapefruit juice \> 8 oz/day
• •No other concurrent anticancer agents or therapies