@article{661640954c92495f91aaba91ff8a1f7e,
title = "EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer",
abstract = "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 ESR1 mutations (ESR1-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 ESR1-mut patients and in all patients (NCT03778931; EudraCT 2018-002990-24).",
keywords = "ESR1 mutation, RAD1901, aromatase inhibitor, breast cancer, elacestrant, endocrine therapy, estrogen receptor (ER)-positive, fulvestrant, selective estrogen receptor degrader (SERD)",
author = "Aditya Bardia and Philippe Aftimos and Teeru Bihani and Anderson-Villaluz, {Alfred T.} and Jungah Jung and Conlan, {Maureen G.} and Kaklamani, {Virginia G.}",
note = "Publisher Copyright: {\textcopyright} 2019 {\textcopyright} 2019 Radius Health, Inc. Lay abstract EMERALD is an international, randomized, open-label, active-controlled, Phase III clinical study comparing the efficacy and safety of an investigational oral hormone therapy, elacestrant (RAD1901), to the standard-of-care hormone therapy options of fulvestrant or an aromatase inhibitor in patients with advanced or metastatic breast cancer that expresses the estrogen receptor (ER-positive) and does not express HER2. The objective of the study is to determine if elacestrant prolongs time until disease progresses in all patients and in patients who have developed a tumor-specific ER mutation that might reduce response to standard hormonal treatments (NCT03778931). {\textcopyright} 2019 {\textcopyright} 2019 Radius Health, Inc.",
year = "2019",
doi = "10.2217/fon-2019-0370",
language = "English (US)",
volume = "15",
pages = "3209--3218",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Taylor and Francis Ltd.",
number = "28",
}