Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
Condition: Breast Cancer; Radiation Toxicity
MeSH terms: Breast Neoplasms
Intervention: lovastatin; questionnaire administration; adjuvant therapy; accelerated partial breast irradiation; external beam radiation therapy
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation toxicity; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; breast cancer in situ

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.
    

Eligibility 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