# Elacestrant

Source: https://onco.cc/drugs/elacestrant/  
OnCo record `elacestrant` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Elacestrant was the first oral oestrogen-receptor degrader (2023), for ESR1-mutant breast cancer detected by blood test.

## Summary

Elacestrant is an oral selective oestrogen receptor degrader (SERD) that binds ER-alpha and promotes its degradation, retaining activity against ESR1 mutations. Taken as 345 mg once daily with food, it was approved in 2023, the first oral SERD, for ESR1-mutant ER-positive, HER2-negative advanced breast cancer after at least one endocrine therapy. In EMERALD the progression-free survival benefit was confined to ESR1-mutant disease, and the Guardant360 CDx blood test is the companion diagnostic, so eligibility is decided by liquid biopsy. Stemline/Menarini markets it. Imlunestrant (Lilly, Inluriyo, 2025) and camizestrant (AstraZeneca, SERENA-6 ctDNA-guided switch) followed, and whether to switch when an ESR1 mutation first appears in blood is the live question. For a newcomer: an oestrogen-blocking pill chosen by a blood test.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Orserdu
- Modality: Oral SERD
- Mechanism: Oral selective ER degrader.
- Approvals: US 2023: ESR1-mutant ER+/HER2- advanced breast cancer after ≥1 endocrine therapy
- Dosing: Oral; 345 mg once daily with food

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Elacestrant
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Elacestrant

## Connected records

- biomarkers: [ER status (oestrogen receptor by IHC)](https://onco.cc/biomarkers/er-status/), [ESR1 mutation (ligand-binding domain, usually in ctDNA)](https://onco.cc/biomarkers/esr1-mutation-ctdna/)
- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/), [FES PET (oestrogen receptor imaging)](https://onco.cc/technologies/fes-pet/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Oral SERDs](https://onco.cc/technologies/oral-serds/)
- targets: [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/)
- companies: [Menarini / Stemline](https://onco.cc/companies/menarini/)
- trials: [A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer](https://onco.cc/trials/nct07766018/), [A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence](https://onco.cc/trials/nct06492616/), [ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study](https://onco.cc/trials/nct05596409/), [EMERALD](https://onco.cc/trials/emerald/), [Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer](https://onco.cc/trials/nct05563220/), [Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer](https://onco.cc/trials/nct05573126/), [Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer](https://onco.cc/trials/nct05386108/)
- terms: [ESR1 mutation](https://onco.cc/terms/esr1-mutation/), [Hormone therapy](https://onco.cc/terms/hormone-therapy/), [Oral SERD](https://onco.cc/terms/oral-serd/), [Selective oestrogen receptor degrader (SERD)](https://onco.cc/terms/serd/)
- pathways: [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [Chemical carcinogenesis - receptor activation](https://onco.cc/pathways/chemical-carcinogenesis-receptor-activation/), [Oestrogen receptor signalling](https://onco.cc/pathways/er-signaling/), [Resistance routes: how a blocked pathway comes back](https://onco.cc/pathways/resistance-routes-map/), [Transcriptional machinery & addiction](https://onco.cc/pathways/transcription-addiction/)
- people: [Aditya Bardia](https://onco.cc/people/aditya-bardia/), [François-Clément Bidard](https://onco.cc/people/francois-clement-bidard/)
- key papers: [EMERALD: elacestrant versus standard endocrine therapy after a CDK4/6 inhibitor](https://onco.cc/key-papers/paper-emerald-elacestrant-jco-2022/)
- drugs: [Guardant360 CDx](https://onco.cc/drugs/guardant360-cdx/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/elacestrant.json