Study of Radiation Therapy Omission After Lumpectomy in Women Aged 50 and Older With Node-Negative Breast Cancer Showing Complete Response After Chemotherapy

What this Trial Is About

This research aims to evaluate the omission of adjuvant whole breast radiation therapy in women with breast cancer who have no clinical evidence of lymph node involvement and have achieved a pathological complete response after neoadjuvant chemotherapy. The study focuses on female patients with newly diagnosed T1-3 node negative breast cancer treated with breast conserving surgery and axillary staging surgery, without distant metastatic disease. The goal is to understand the impact of skipping radiation therapy on breast cancer outcomes. Participants will not receive the usual adjuvant whole breast radiation therapy following breast conserving surgery. Instead, they will be followed over time to monitor their health status. The study is designed as a single arm cohort, meaning all enrolled women who meet the criteria will be observed without receiving radiation therapy. The first analysis is planned after a median follow-up of 5 years. Throughout the study, participants will undergo regular assessments to check for local, regional, and distant recurrence of breast cancer, as well as disease-free survival and overall survival. Any additional breast cancer treatments received after recurrence, such as repeat surgery, systemic therapy, or radiation, will be documented. The total participation duration is planned to extend up to 5 years, with ongoing monitoring to measure outcomes and safety.

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy