Actively Recruiting
Trial Comparing Partial Breast Irradiation Versus No Radiation for Women 60 Years and Older After Breast-Conserving Surgery for Early Breast Cancer
Led by Danish Breast Cancer Cooperative Group · Updated on 2020-10-06
926
Participants Needed
17
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether some women aged 60 or older with early breast cancer can safely skip radiation therapy after breast conserving surgery. The study focuses on patients with low-risk breast cancer, aiming to identify who might avoid radiation without a high chance of cancer returning locally. This is important because radiation can cause both short-term and long-term side effects, and not all patients gain the same benefit from it. The trial compares two approaches one group will receive partial breast irradiation using external beam radiation at a dose of 40 Gy divided into 15 fractions over 3 weeks, while the other group will receive no radiation therapy. This comparison will help determine if radiation can be omitted safely in selected low-risk patients. The study is randomized and does not use any masking or blinding. Participants will be monitored over 10 years to measure invasive local recurrence of cancer as the primary outcome. Researchers will also track regional lymph node recurrence, distant failure, and death. Patients will have regular assessments to evaluate these outcomes and any side effects. The total follow-up period ensures long-term safety and effectiveness data for the treatment approaches.
CONDITIONS
Brief Title
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
Research Team
B
Birgitte V Offersen, PhD
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