Breast Cancer Clinical Trial
Official title:
A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer
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.
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.
OUTLINE: Patients undergo standard external beam whole-breast irradiation and/or accelerated
partial breast irradiation. Patients receive oral lovastatin once daily beginning on the
first day of radiotherapy and continuing for 12 months in the absence of disease progression
or unacceptable toxicity.
Patients complete a questionnaire, the Breast Cancer Treatment Outcome Scale, at baseline
and then at 6 months, 12 months, and 3 years after completion of radiotherapy to assess
cosmetic and functional outcomes.
After completion of radiotherapy, patients are followed periodically for up to 5 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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