Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer (HERO)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Wahl, Andrew
Contact Information:
Abalyn Moehring
amoehring@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05705401?term=NCT05705401&rank=1
Summary
1.1 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.
1.2 Secondary Objectives
1.2.1 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.
1.2.2 To estimate time to ipsilateral breast recurrence (IBR) by treatment arm.
1.2.3 To determine the time to local regional recurrence (LRR) by treatment arm.
1.2.4 To determine disease-free survival (DFS) by treatment arm.
1.2.5 To determine overall survival (OS) by treatment arm.
1.2.6 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.
1.2.7 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.
1.3 Exploratory Objective
To explore important measures of quality of life that would reasonably be expected to vary by study arm, including cosmesis, breast-related functional status, fatigue, breast and skin symptoms, and global quality of life.