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The first oral oestrogen-receptor degrader to beat standard hormone therapy, with the benefit concentrated in tumours carrying ESR1 mutations.
EMERALD, trial NCT03778931 sponsored by Radius and Menarini and reported in 2021, was the first trial in which an oral oestrogen receptor degrader beat standard hormone therapy, with the benefit concentrated in tumours carrying ESR1 mutations. It randomised 478 women with ER-positive, HER2-negative advanced breast cancer after one or two endocrine lines including a CDK4/6 inhibitor to elacestrant or standard endocrine therapy, met its primary progression-free survival endpoints in the whole population and the ESR1-mutant group, with a larger effect in the mutant group that grew with longer prior CDK4/6 exposure, and led to approval in January 2023 for ESR1-mutant disease with a ctDNA companion diagnostic. The ESR1-restricted benefit was replicated by EMBER-3 and VERITAC-2, and whether oral SERDs help without the mutation remains open.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
478 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (ESR1-mutant)primary | Elacestrant | 115 | 3.8 months | 0.55 (0.39 to 0.77) | 0.0005 | link |
| Standard endocrine therapy | 113 | 1.9 months | ||||
| Progression-free survival (all patients)primary | Elacestrant | 239 | 2.8 months | 0.7 (0.55 to 0.88) | 0.002 | link |
| Standard endocrine therapy | 239 | 1.9 months |
Shares Selective oestrogen receptor degrader (SERD), ESR1 mutation, Elacestrant, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs).
Shares ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
Shares Selective oestrogen receptor degrader (SERD), ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).