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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 chemotherapy because of large tumors or significant lymph node involvement, even though their tumors may have lower-risk biology.

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) has launched the RxFINE-Low (EA1242) trial to determine whether chemotherapy provides additional benefit for this subgroup.

"RxFINE-Low seeks to answer a critical question in breast cancer care, which is: Can patients with high anatomic risk but low genomic risk do similarly well without chemotherapy?" said study chair Nancy Chan, MD, a medical oncologist at New York University's Perlmutter Cancer Center at NYU Langone.

Adjuvant chemotherapy is generally not recommended for postmenopausal patients with earlier-stage ER+/HER2- breast cancer who have low Oncotype DX scores and cancer in up to three lymph nodes, based on findings from the landmark TAILORx and RxPONDER trials.

However, whether chemotherapy can also be omitted in patients with larger tumors or more extensive lymph node involvement has never been evaluated in a large prospective randomized trial. As a result, chemotherapy remains the standard approach for these patients.

The NATALEE and monarchE trials established the benefit of adding a CDK4/6 inhibitor to endocrine therapy in high-risk, early-stage ER+/HER2- breast cancer.

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