Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen. SECONDARY OBJECTIVES: I. To measure patient-reported cosmetic...

PRIMARY OBJECTIVE: I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen. SECONDARY OBJECTIVES: I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen. II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559. III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer. IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival. V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale. VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo hypofractionated partial breast irradiation daily for 10 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.

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