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

Inclusion Criteria

• •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