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. 2025 Jul;21(16):2017-2025.
doi: 10.1080/14796694.2025.2511586. Epub 2025 Jun 26.

NRG-BR008/HERO study: a Phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer

Lior Z Braunstein  1 , Melissa P Mitchell  2 , Hanna Bandos  3 , William M Sikov  4 , Atif J Khan  1 , Peter Y Chen  5 , Patricia A Ganz  6 , Reshma Jagsi  7 , Julia R White  8 , Reena S Cecchini  3 , Hyejoo Kang  9 , Shannon L Puhalla  10 , Kelly L Bolton  11 , Eileen P Connolly  12 , Erica M Stringer-Reasor  13 , Kimberly R Gergelis  14 , Thomas B Julian  15 , Eleftherios P Mamounas  16 , Norman Wolmark  17
Affiliations

NRG-BR008/HERO study: a Phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer

Lior Z Braunstein et al. Future Oncol. 2025 Jul.

Abstract

NCT05705401 (ClinicalTrials.gov).

Keywords: Breast-conservation therapy; HER2-positive breast cancer; HER2-targeted therapy; adjuvant breast radiotherapy; breast cancer treatment; oncological outcomes; quality of life outcomes.

Plain language summary

HER2-positive breast cancer was historically unfavorable, with high rates of local and distant recurrence, but is now known to respond well to targeted treatments such as trastuzumab. Targeted therapy has reduced local recurrence rates in some studies to less than 1% and has dramatically improved overall outcomes. Considering the excellent prognosis of this subtype of breast cancer, and the availability of highly effective HER2-targeted agents, it is unclear if radiotherapy adds additional benefit to patients. This Phase III study, NRG-BR008 (HERO), is exploring whether some patients with early-stage, low-risk HER2-positive breast cancer can safely skip radiotherapy after surgery and targeted drug treatments. By skipping radiotherapy, these patients might avoid side effects without increasing their risk of the cancer coming back. In the trial, patients who have received surgery and standard drug treatments are randomly assigned to one of two groups: one group receives breast radiotherapy per the discretion of the treating physician, while the other group does not. Researchers will closely follow each group for the return of breast cancer. The study also looks at how skipping radiotherapy affects overall health and quality of life. For instance, it will measure whether patients who do not receive radiotherapy have less breast pain or more worry about cancer coming back. If successful, the trial could lead to a simpler and more comfortable treatment approach for low-risk patients while ensuring they still receive excellent care.

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References

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    2. • of interest.

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    2. •• of considerable interest.

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