Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of invasive or in situ epithelial cancer of the breast
• * Stage 0, I, or II (Tis, T1, or T2) disease
• * Unifocal disease (single focus that can be encompassed by breast-conserving surgery)
• Has undergone prior surgical resection of the primary lesion (lumpectomy) and axillary nodal evaluation (if invasive disease is present)
• * Negative surgical margins (≥ 1 mm)
• Planning to undergo radiotherapy with either standard external beam radiotherapy or accelerated partial breast irradiation (interstitial or balloon brachytherapy)
• No Paget disease of the nipple
• No evidence of distant metastases
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• Karnofsky performance status 70-100%
• Transaminases \< 3 times upper limit of normal (ULN)
• Creatine kinase \< 5 times ULN
• Creatinine clearance ≥ 30 mL/min
• Negative pregnancy test
• No active liver or muscle disease
• No history of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
• History of prior malignancy allowed provided life expectancy is ≥ 4 years
• No major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of study treatment or interfere with follow-up
• No contraindication to an HMG-coA-reductase inhibitor
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior radiotherapy to the breast, lung, or mediastinum
• * Prior radiotherapy to the contralateral breast allowed
• No chemotherapy for ≥ 2 weeks prior to, during, and for ≥ 2 weeks after completion of radiotherapy
• No concurrent cytochrome P450 3A4 inhibitors
• Concurrent HMG-coA-reductase inhibitor allowed provided patient is able to switch to 20 mg of lovastatin per day
• Concurrent tamoxifen or an aromatase inhibitor allowed