Landmark trial evaluates chemotherapy benefit in high-risk early-stage breast cancer
The addition of CDK4/6 inhibitors to endocrine therapy has changed the standard of care for patients with high-risk, early-stage estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer by reducing the risk of recurrence. However, one patient subgroup continues to present a clinical dilemma. In current practice, patients with low genomic risk but high anatomic risk receive adjuvant…
The ECOG-ACRIN Cancer Research Group has initiated the RxFINE-Low (EA1242) trial to investigate whether chemotherapy is beneficial for patients with high-anatomic-risk, early-stage estrogen receptor-positive, HER2-negative breast cancer who exhibit low genomic risk. Current practice sees these patients receiving adjuvant chemotherapy due to large tumor size or extensive lymph node involvement, despite their lower-risk tumor biology.
The trial aims to determine if chemotherapy can be omitted in such patients without compromising outcomes. RxFINE-Low will enroll nearly 2,000 postmenopausal individuals with high-anatomic-risk breast cancer but low genomic risk, as defined by an Oncotype DX Breast Recurrence Score between 0 and 25. Participants will be randomly assigned to receive either adjuvant chemotherapy followed by endocrine therapy and a CDK4/6 inhibitor (ribociclib) or endocrine therapy with ribociclib alone.
The primary endpoint is invasive breast cancer-free survival, with the trial assessing outcomes over a 10-year follow-up period. Researchers will also collect tumor tissue and blood samples for future translational studies. If successful, the trial's findings could spare patients from chemotherapy's short- and long-term toxicities and inform future coverage decisions, as genomic testing has not been validated for high-anatomic-risk breast cancer patients.
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