Study of Adjuvant Chemoradiation Therapy and Immune Response in High-risk Breast Cancer Patients Following Neoadjuvant Chemotherapy and Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who have residual disease after receiving neoadjuvant chemotherapy and surgery. The study also aims to examine how this treatment affects the immune system. This research focuses on breast cancer stages I to IIIB and seeks to improve outcomes in patients at increased risk of recurrence. Participants will receive treatment based on their HER2 status. Those who are HER2 positive will receive T-DM1 trastuzumab emtansine infusions every three weeks for up to 14 cycles alongside radiation therapy to the breast or chest wall and lymph nodes. HER2 negative patients will take oral capecitabine twice daily for six months while also receiving radiation. Radiation doses are given in 15 fractions over 15 to 19 days, with possible additional boosts depending on the treatment area. The study includes different groups based on HER2 status and lymph node involvement. During the study, participants will have blood samples collected at multiple times to monitor immune responses and will complete surveys about their overall health and wellbeing. Researchers will assess safety by monitoring treatment side effects and delays over one year. They will also evaluate cosmetic outcomes of radiation using specific scales and breast measurements. The study runs until December 2029, with close follow-up to understand treatment feasibility and impact on patient health.

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer