Massachusetts General Hospital Cancer Center, Departments of Medicine and Hematology/Oncology, 55 Fruit Street Boston, MA 02114-3411, USA.
Clinical Trials Conduct Unit, Institut Jules Bordet, Université Libre de Bruxelles, Rue Heger-Bordet1, 1000 Brussels, Belgium.
Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.
Elacestrant is a novel, nonsteroidal, orally bioavailable selective estrogen receptor degrader (SERD) that has demonstrated activity in patients with estrogen receptor (ER)-positive/HER2-negative breast cancer previously treated with endocrine therapies including fulvestrant and/or CDK 4/6 inhibitor therapy, and in those with mutations (-mut) known to confer endocrine resistance. Herein, we describe the design and methodology of EMERALD, an international, multicenter, randomized, open-label, active-controlled, Phase III clinical study comparing the efficacy and safety of elacestrant to standard-of-care endocrine monotherapy treatment (fulvestrant or an aromatase inhibitor, per investigator's choice) in patients with ER-positive/HER2-negative advanced breast cancer. Primary end points are progression-free survival in -mut patients and in all patients (NCT03778931; EudraCT 2018-002990-24).
依维莫司是一种新型、非甾体类、口服生物可利用的选择性雌激素受体降解剂（SERD），在先前接受过内分泌治疗（包括氟维司群和/或 CDK4/6 抑制剂治疗）的雌激素受体（ER）阳性/HER2 阴性乳腺癌患者以及存在已知导致内分泌耐药的 突变（-mut）的患者中显示出疗效。在此，我们描述了 EMERALD 的设计和方法，这是一项国际性、多中心、随机、开放标签、阳性对照、III 期临床研究，比较了依维莫司与标准内分泌单药治疗（氟维司群或芳香化酶抑制剂，由研究者选择）在 ER 阳性/HER2 阴性晚期乳腺癌患者中的疗效和安全性。主要终点是 -mut 患者和所有患者的无进展生存期（NCT03778931；EudraCT 2018-002990-24）。
