The FDA has granted approval to abemaciclib (Verzenio®, Eli Lilly and Company) with endocrine therapy—tamoxifen or an aromatase inhibitor—for treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer that is at a high risk of recurrence. Patients considered at high risk for recurrence include those with four or more pathologic axillary lymph nodes (pALN) or one to three pALN plus either a grade 3 t...

The FDA has approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with endocrine therapy consisting of an aromatase inhibitor or tamoxifen as adjuvant therapy for patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer with a high risk of recurrence. Abemaciclib, the first CDK4/6 inhibitor to be approved in the adjuvant breast cancer setting, is indicated for patients with a Ki-67 score of ≥20%. In...

Using circulating tumor cell (CTC) count to determine whether chemotherapy or endocrine therapy is used improves survival outcomes compared with clinically determined treatment in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, according to the results of the open-label, randomized phase 3 STIC CTC trial published today in JAMA Oncology. The investigators, led by François-Clément Bidard, MD, PhD, Professor of Medicine at the University of Paris-Sac...

 Endocrine therapy plus cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors improved overall survival, progression-free survival, and objective response rate for patients with hormone receptor–positive, HER2-negative metastatic breast cancer, according to results of a meta-analysis published recently in JAMA Oncology. The finding supports continued use of endocrine therapy plus CDK4/6 inhibitor combinations in clinical trials. The investigators, led by first author Jinming Li, BD, a pr...