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 launched the RxFINE-Low (EA1242) trial to evaluate whether chemotherapy provides additional benefit for high-risk, early-stage breast cancer patients with high anatomic risk but low genomic risk. Current practice involves giving adjuvant chemotherapy to patients with large tumors or significant lymph node involvement, even though their tumors may have lower-risk biology.
The RxFINE-Low trial will enroll nearly 2,000 postmenopausal patients with high anatomic risk breast cancer and 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 plus a CDK4/6 inhibitor or endocrine therapy plus ribociclib alone.
The primary endpoint is invasive breast cancer-free survival, and the trial will follow participants for up to 10 years to evaluate recurrence, survival, treatment-related side effects, and other study endpoints.
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