@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 = "Funding Information: This study was funded by Radius Health, Inc. on behalf of its wholly owned subsidiary, Radius Pharmaceuticals, Inc. A Bardia reports grants and personal fees from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Inc., Immunomedics, and Biothernostics, Inc.; grants from Mersana and Innocrin; and personal fees from Spectrum Pharma, Taiho, Daiichi Pharma and Puma Pharma, outside the submitted work. P Aftimos reports personal fees from Boehringer Ingleheim, Macrogenics, Synthon, Novartis, Roche, Amgen and Amcure; and nonfinancial support from Amgen, MSD, Pfizer and Roche, outside the submitted work. VG Kaklamani has received personal fees from Novartis, Pfizer, Genentech, Genomic Health, Puma, Celgene, Celldex, AstraZeneca and Amgen; personal fees and grant funding from Eisai; and nonfinancial support from Athenex. T Bihani, AT Anderson-Villaluz, J Jung and MG Conlan are employees and shareholders of Radius Health, Inc. Financial support for this work was provided by Radius Health, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. 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 = "Future Medicine Ltd.",
number = "28",
}