Phase II Study Evaluating AI-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery Assessing Safety and Effectiveness Compared to Standard IMRT

What this Trial Is About

Breast cancer became the most common cancer worldwide in 2020, and radiotherapy after breast-conserving surgery is important for many patients. Researchers are studying an AI-assisted All-in-one AIO radiotherapy method that combines several steps such as target area outlining and treatment planning to make the process faster and more accurate. This phase II clinical trial aims to evaluate whether this AIO approach is feasible, effective, and safe, while providing a foundation for standard procedures. The trial compares two radiotherapy methods given to female breast cancer patients the experimental AIO radiotherapy covering the breast and regional lymph nodes, and the conventional intensity-modulated radiation therapy IMRT covering the same areas. Participants will receive radiotherapy after surgery and may also undergo endocrine or targeted therapies if needed. The study is non-randomized and includes a parallel external control group to assess outcomes over about one year. Participants will be monitored for adverse effects for 12 months after radiotherapy ends, and researchers will measure overall survival and disease-free survival during the study. Patients need to be able to tolerate lying still for about 30 minutes during treatment and agree to follow-up visits. The study is sponsored by Sun Yat-sen University and aims to better understand the safety and impact of AI-assisted radiotherapy for breast cancer treatment.

A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery