Ribociclib Plus Endocrine Therapy in Hormone Receptor–Positive/-Negative Early Breast Cancer
JAMA Oncology 10.1001/jamaoncol.2025.3700September 25, 2025 at 11:00 AM EDT
Is the efficacy benefit of ribociclib sustained beyond the planned 3-year treatment duration for patients with hormone receptor–positive/(formerly )-negative early breast cancer in the NATALEE randomized clinical trial?In this exploratory 4-year analysis of 5101 patients from the NATALEE trial, ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) continued to demonstrate an invasive disease-free survival and distant disease-free survival benefit over NSAI alone by reducing the disease recurrence risk by 28.5%. The absolute iDFS benefit continued to increase from 3 to 4 years.NATALEE results continue to support the benefit of adding 3 years of ribociclib to adjuvant NSAI in patients with hormone receptor–positive/-negative early breast cancer at risk of recurrence.
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