EMERALD
Trial question
What is the role of elacestrant in patients with ER+/HER2- advanced breast cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
99.0% female
1.0% male
N = 477
477 patients (470 female, 7 male).
Inclusion criteria: patients with ER+/HER2- advanced breast cancer who had 1-2 lines of endocrine therapy pretreated with a CDK4/6 inhibitor and ≤ 1 chemotherapy.
Key exclusion criteria: symptomatic metastatic visceral disease; any of the following CV events within 6 months of enrolment: severe/unstable angina, MI, coronary/peripheral artery bypass graft, prolonged corrected QT interval grade ≥ 2, uncontrolled AF, ongoing grade ≥ 2 cardiac dysrhythmias, ≥ class II NYHA HF, coagulopathy, or cerebrovascular accident.
Interventions
N=239 elacestrant (at an oral dose of 400 mg/day).
N=238 standard of care (fulvestrant, anastrozole, letrozole, or exemestane monotherapy).
Primary outcome
Progression-free survival in overall population
39.7%
34.5%
39.7 %
29.8 %
19.9 %
9.9 %
0.0 %
Elacestrant
Standard of
care
Significant
increase ▲
NNT = 19
Significant increase in progression-free survival in overall population (39.7% vs. 34.5%; HR 1.43, 95% CI 1.14 to 1.82).
Secondary outcomes
Significant increase in progression-free survival in estrogen receptor 1-mutated population (46.1% vs. 31%; HR 1.82, 95% CI 1.3 to 2.56).
No significant difference in overall survival in overall population (70.7% vs. 66.8%; HR 1.33, 95% CI 0.96 to 1.85).
Significant increase in overall survival in estrogen receptor 1-mutated population (75.7% vs. 64.6%; HR 1.7, 95% CI 1.04 to 2.78).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with ER+/HER2- advanced breast cancer who had 1-2 lines of endocrine therapy pretreated with a CDK4/6 inhibitor and ≤ 1 chemotherapy, elacestrant was superior to standard of care with respect to a progression-free survival in overall population.
Reference
Francois-Clement Bidard, Virginia G Kaklamani, Patrick Neven et al. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256.
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