Title (RTOG 1005) A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
Principal Investigator David Mattson, MD
Study Number 202411
Summary The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 1/2 weeks. It is not expected that there would be a difference in survival by changing the number of daily treatments and shortening the length of time needed for treatment. However, shortening treatment length could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning compared to standard daily doses of radiation.
- pStage 0, I, II Breast Cancer resected by lumpectomy OR ypStage 0, I, II Breast Cancer resected by lympectomy that followed neoadjuvant systemic therapy and must be within 42 days of last breast/axillary surgery and/or last chemotherapy
- pStage I, II Breast Cancer and at least one of the following: Age < 50 years, Positive axillary nodes, Lymphovascular space invasion, More than 2 close resection margins, Grade III histology, Oncotype recurrence score > 25.
- pStage 0 breast cancer with nuclear grade 3 DCIS and patient age < 50 years.
- ypStage 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy.
- If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins. No prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to registration.
- No prior invasive or in-situ carcinoma of the breast.
- DCIS and age greater than or equal to 50 years or < 50 years and nuclear grade 1 or 2 are ineligible.