EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer

Aditya Bardia; Philippe Aftimos; Teeru Bihani; Alfred T. Anderson-Villaluz; Jungah Jung; Maureen G. Conlan; Virginia G. Kaklamani

doi:10.2217/fon-2019-0370

EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer

Aditya Bardia
, Philippe Aftimos
, Teeru Bihani
, Alfred T. Anderson-Villaluz
, Jungah Jung
, Maureen G. Conlan
, Virginia G. Kaklamani

Research output: Contribution to journal › Review article › peer-review

59 Scopus citations

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).

Original language	English (US)
Pages (from-to)	3209-3218
Number of pages	10
Journal	Future Oncology
Volume	15
Issue number	28
DOIs	https://doi.org/10.2217/fon-2019-0370
State	Published - 2019
Externally published	Yes

Keywords

ESR1 mutation
RAD1901
aromatase inhibitor
breast cancer
elacestrant
endocrine therapy
estrogen receptor (ER)-positive
fulvestrant
selective estrogen receptor degrader (SERD)

ASJC Scopus subject areas

Oncology
Cancer Research

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@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",

}

TY - JOUR

T1 - EMERALD

T2 - Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer

AU - Bardia, Aditya

AU - Aftimos, Philippe

AU - Bihani, Teeru

AU - Anderson-Villaluz, Alfred T.

AU - Jung, Jungah

AU - Conlan, Maureen G.

AU - Kaklamani, Virginia G.

N1 - Publisher Copyright: © 2019 © 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). © 2019 © 2019 Radius Health, Inc.

PY - 2019

Y1 - 2019

N2 - 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).

AB - 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).

KW - ESR1 mutation

KW - RAD1901

KW - aromatase inhibitor

KW - breast cancer

KW - elacestrant

KW - endocrine therapy

KW - estrogen receptor (ER)-positive

KW - fulvestrant

KW - selective estrogen receptor degrader (SERD)

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UR - https://www.scopus.com/pages/publications/85073666215#tab=citedBy

U2 - 10.2217/fon-2019-0370

DO - 10.2217/fon-2019-0370

M3 - Review article

C2 - 31426673

AN - SCOPUS:85073666215

SN - 1479-6694

VL - 15

SP - 3209

EP - 3218

JO - Future Oncology

JF - Future Oncology

IS - 28

ER -

EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer

Abstract

Keywords

ASJC Scopus subject areas

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