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

12 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 - Jan 1 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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EMERALD : Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. / Bardia, Aditya; Aftimos, Philippe; Bihani, Teeru; Anderson-Villaluz, Alfred T.; Jung, Jungah; Conlan, Maureen G.; Kaklamani, Virginia G.

In: Future Oncology, Vol. 15, No. 28, 01.01.2019, p. 3209-3218.

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

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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).",

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