# EMERALD: elacestrant versus standard endocrine therapy after a CDK4/6 inhibitor

Source: https://onco.cc/key-papers/paper-emerald-elacestrant-jco-2022/  
OnCo record `paper-emerald-elacestrant-jco-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: Journal of Clinical Oncology
- Year: 2022
- DOI: 10.1200/JCO.22.00338
- Authors: Bidard FC, Kaklamani VG, Neven P, et al.
- Findings: 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.
- What it means: 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.
- Caveats: Absolute benefit is small and control-arm performance was poor.; Nausea and lipid changes are common.

## Sources

- J Clin Oncol 2022: https://doi.org/10.1200/JCO.22.00338
- PubMed: https://pubmed.ncbi.nlm.nih.gov/35584336/

## Connected records

- cancers: [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- drugs: [Elacestrant](https://onco.cc/drugs/elacestrant/)
- trials: [EMERALD](https://onco.cc/trials/emerald/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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