Lovastatin in Reducing Side Effects After Radiation Therapy in Women With 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.
Other: questionnaire administration
Procedure: adjuvant therapy
Radiation: accelerated partial breast irradiation
Radiation: external beam radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer|
- Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy [ Time Frame: during the first 5 years after treatment ] [ Designated as safety issue: No ]Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale
|Study Start Date:||April 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (lovastatin)
Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
|Drug: lovastatin Other: questionnaire administration Procedure: adjuvant therapy Radiation: accelerated partial breast irradiation Radiation: external beam radiation therapy|
- 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.