Mirat Shah, Hima Lingam, Xin Gao, Haley Gittleman, Mallorie H Fiero, Danielle Krol, Nikolett Biel, Tiffany K Ricks, Wentao Fu, Salaheldin Hamed, Fang Li, Jillian Jielin Sun, Jianghong Fan, Robert Schuck, Manuela Grimstein, Liuya Tang, Shyam Kalavar, Abdelrahmman Abukhdeir, Anand Pathak, Soma Ghosh, Ilynn Bulatao, Amy Tilley, William F Pierce, Bronwyn D Mixter, Shenghui Tang, Richard Pazdur, Paul Kluetz, Laleh Amiri-Kordestani
PURPOSE: The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy (ET). PATIENTS AND METHODS: Approval was based on EMERALD (Study RAD1901-308), a randomized, open-label, active-controlled, multicenter trial in 478 patients with ER+, HER2- advanced or metastatic breast cancer, including 228 patients with ESR1 mutations...
April 1, 2024: Journal of Clinical Oncology