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) |
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Pages (from-to) | 3209-3218 |
Number of pages | 10 |
Journal | Future Oncology |
Volume | 15 |
Issue number | 28 |
DOIs | |
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