NRG-BR008/HERO study: a Phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer
Lior Z. Braunstein, Melissa P. Mitchell, Hanna Bandos, William M. Sikov, Atif J. Khan, Peter Y. Chen, Patricia A. Ganz, Reshma Jagsi, Julia White, Reena S. Cecchini, Hyejoo Kang, Shannon L. Puhalla, Kelly L. Bolton, Eileen P. Connolly, Erica Stringer-Reasor, Kimberly R. Gergelis, Thomas B. Julian, Eleftherios P. Mamounas, Norman Wolmark
Abstract
HER2-positive breast cancer historically had the highest rates of recurrence but has substantially improved outcomes with the advent of targeted anti-HER2 therapies. NRG-BR008/HERO is a Phase III randomized trial evaluating whether adjuvant radiotherapy remains beneficial in low-risk HER2-positive breast cancer treated with HER2-targeted therapies. Patients are randomly assigned to receive either standard radiotherapy or observation after breast-conserving surgery. The primary endpoint is a recurrence-free interval, with secondary endpoints including 7-year ipsilateral breast recurrence, disease-free survival, overall survival, and patient-reported outcomes including worry and breast pain.Clinical Trial Registration NCT05705401 (ClinicalTrials.gov).