Breast-Conserving Surgery and Whole-Breast Radiation Therapy With or Without Additional Radiation Therapy to the Tumor in Treating Women With Ductal Carcinoma in Situ (BONBIS)

Overview

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

OBJECTIVES: Primary * Estimate and compare local recurrence-free survival of women with ductal breast carcinoma in situ (DCIS) treated with breast-conserving surgery followed by whole breast irradiation with vs without a radiation tumor bed boost. Secondary * Compare relapse-free survival between the two arms. * Compare overall survival. * Compare acute and late toxicities. * Compare cosmetic results and quality of life. * Identify patients at risk for late toxicities using a biological test. Tertiary * Store blood samples at the CEPH (French Center of the Human Polymorphism Center) for polymorphism analyses. OUTLINE: This is a multicenter study. All patients undergo breast-conserving surgery (after a single intervention or second excision) with a margin ≥ 1 mm. A superficial or deep margin is acceptable if the surgery has left the skin tissue or the fascia pectoral muscle, respectively. Twelve weeks later, patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5 weeks. * Arm II: Patients undergo WBI as in arm I. Patients also undergo a radiation tumor bed boost once daily for 8 fractions (weekdays only) over 2 weeks. Quality of life will be assessed. After completion of study treatment, patients are followed up every 6 months for 5 years and then annually for 10 years.