NRG-BR008: A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)
Objective
Primary Objective: To compare the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the current standard of care.
Secondary Objectives: To estimate 7-year cumulative incidence ipsilateral breast recurrence (IBR) for radiation omitting arm and test the hypothesis that the 7-year IBR rate is <7% for patients not receiving adjuvant breast radiotherapy. To estimate time to ipsilateral breast recurrence (IBR) by treatment arm. To determine the time to local regional recurrence (LRR) by treatment arm. To determine disease-free survival (DFS) by treatment arm. To determine overall survival (OS) by treatment arm. To evaluate whether there is a difference in patient-reported breast pain in patients who do and do not receive breast radiation in cohort A and cohort B. To evaluate whether there is a difference in patient-reported worry about recurrence in patients who do and do not receive breast radiation in cohort A and cohort B.
