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Actively Recruiting

Phase Not Applicable
Age: 60Years +
FEMALE
ID03646955

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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