EMERALD: elacestrant versus standard endocrine therapy after a CDK4/6 inhibitor
The oral oestrogen receptor degrader elacestrant delayed progression compared with standard hormone therapy in advanced breast cancer that had progressed on a CDK4/6 inhibitor, with the clearest benefit in tumours carrying an ESR1 mutation.
Overview
Phase 3 trial of 477 patients with oestrogen receptor-positive, HER2-negative advanced breast cancer previously treated with one or two lines of endocrine therapy including a CDK4/6 inhibitor, randomised to elacestrant or investigator's choice of fulvestrant or an aromatase inhibitor.
Progression-free survival was improved overall (hazard ratio 0.70) and in the ESR1-mutated group (hazard ratio 0.55), where median progression-free survival was 3.8 versus 1.9 months; benefit was largest in patients with longer prior CDK4/6 inhibitor exposure.
- Progression-free survival hazard ratio 0.70 overall and 0.55 in ESR1-mutated disease.
- Median progression-free survival 3.8 vs 1.9 months in ESR1-mutated tumours.
Elacestrant is the first oral selective oestrogen receptor degrader approved, for ESR1-mutated disease after a CDK4/6 inhibitor. Absolute gains are modest and blood testing for ESR1 mutations is now routine at progression.
- Absolute benefit is small and control-arm performance was poor.
- Nausea and lipid changes are common.
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