January 14 2025
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 (Herceptin). Targeted therapy has reduced local recurrence rates in some studies to less than 1% and has dramatically improved overall outcomes, allowing patients to be treated more effectively to live longer. Considering the excellent prognosis of this subtype of breast cancer, and the availability of highly effective targeted agents, it is unclear if radiation therapy adds additional benefit to patients beyond other treatments.
NRG-BR008 (the HERO trial), is exploring whether some patients with early-stage, low-risk HER2-positive breast cancer can safely skip radiotherapy after surgery and targeted therapy to reduce side effects while maintaining low recurrence and a high quality of life.
The trial was activated in March of 2023; however, accrual has not been as robust as anticipated.The BR008 Investigators received feedback as to the possible reasons for the trial not accruing at the levels anticipated, which led to the protocol being amended.
The following protocol changes were made in response to the feedback received.
- Allowable tumor size in both cohorts was increased
- Small volume DCIS in the neoadjuvant arm is now permitted
- Systemic therapy options were expanded
- Age for eligibility was revised to ≥ 18 years of age
- More freedom with radiation regimens is permitted
- Minimum number of systemic therapy cycles was reduced
The activation of the amendment will be announced in an upcoming NRG Broadcast.