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

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of radiation therapy.

PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects after radiation therapy in women with breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Dihydromevinolin; L 647318; Lovastatin

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