Clinical Trial

Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

Study acronym: HERO
Active, Not Recruiting Phase 3
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Summary
This Phase III trial compares 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 standard of care.
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2023-01-20; most recent amendment 2026-04-22.
Status change: Recruiting → Active, Not Recruiting 2026-04-22
Status change: Active, Not Recruiting → Recruiting 2023-04-25
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-04-12
Trial Details
NCT Number NCT05705401
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI), Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, SWOG Cancer Research Network
Conditions HER2-positive Breast Cancer
Enrollment 1,300 participants
Start Date 2023-05-19
Primary Completion 2034-02-01 (estimated)
Study Completion 2037-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-27