The FDA has approved elacestrant (Orserdu™, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor 1 (ESR1)–mutated advanced or metastatic breast cancer with disease progression subsequent to at least one line of endocrine therapy. Additionally, the FDA approved the Guardant360 CDx assay, a companion diagnostic test, to identify breast cancer patients eligible for treatme...

 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...

​A phase 3 clinical trial reports that tucidinostat (Epidaza®, Chipscreen Biosciences Ltd) in combination with exemestane (Aromasin®, Pfizer Inc.) improves progression-free survival compared with exemestane alone in postmenopausal patients with advanced, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer experiencing disease progression following prior endocrine therapy. Also known as chidamide, tucidinostat is an orally bioavailable subtype-se...

​Updated results from MONARCH 2 report that adding abemaciclib (Verzenio®, Eli Lilly) to fulvestrant (Faslodex®, AstraZeneca) improves overall survival compared with fulvestrant alone in patients with endocrine-refractory hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. "Most patients with metastatic breast cancer have tumors that are HR-positive and are initially treated with endocrine therapy. Although endocrine therapy is an effi...