Status:
TERMINATED
Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Breast Cancer
Radiation Toxicity
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: * To determine the incidence of good/excellent cosmetic outcome, as defined by the Harvard Scale, after radiotherapy in women treated with lovastatin, as compared to historical controls. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00902668
Start Date
April 1 2009
End Date
April 1 2013
Last Update
June 20 2013
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