marked.bio

oral SERD · small molecule

elacestrant

9 active trials across 4 of our biomarkers, targeting ER. 2 active approvals for a biomarker on marked.bio.

Also known as RAD1901, Orserdu.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
elacestrant
FDA, 2023
advanced or metastatic, ESR1-mutated, after >=1 line of endocrine therapy FDA approval 27/01/2023; companion test Guardant360 CDx. Source
EU (EMA), 2023
locally advanced or metastatic, activating ESR1 mutation, after >=1 line of endocrine therapy including a CDK4/6 inhibitor EU marketing authorisation 15/09/2023. Source
Orserdu 		ESR1 mutation breast (ER+/HER2-) Approved 2023 Approved 2023

EMERALD vs fulvestrant or an aromatase inhibitor, 228 with ESR1 mutation
PFS 3.8 months vs 1.9 months, HR 0.55 (0.39-0.77)

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer after CDK4/6 inhibitor (NCT03778931)
Most common side effects
musculoskeletal pain, nausea, raised cholesterol, raised AST, raised triglycerides, fatigue, low haemoglobin, vomiting
Notes
FDA approval summary (2023); side effects are those in 10% or more of patients.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ESR1 mutation 5 5 Phase 3
PIK3CA activating mutation 2 2 Phase 1/2
BRCA1/2 mutation 1 1 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 1 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of elacestrant.

  1. Stemline Therapeutics 3

Trials

9 of 9 trials shown

  1. Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

    Recruiting Phase 3 MedSIR Started 2024Primary completion 2027-09 NCT06382948

    everolimuselacestrant FDA EUdexamethasoneAuxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analo

    Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

    ESR1 mutationAdvanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation

  2. PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

    Recruiting Phase 2 Kristina A. Fanucci Started 2026Primary completion 2029-12 NCT07222215

    capecitabineelacestrant FDA EU

    ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y5…

    ESR1 mutationEstrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Breast Cancer

  3. A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer

    Recruiting Phase 2 Stemline Therapeutics Started 2026Primary completion 2028-10 NCT07766018

    elacestrant FDA EU

    Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prio…

    ESR1 mutationBreast Cancer

  4. ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

    Recruiting Phase 1/2 Kristina A. Fanucci Started 2025Primary completion 2028-06 NCT07198724

    elacestranttrastuzumab deruxtecan FDA EUtrastuzumab

    Participants must have a histologically or cytologically confirmed diagnosis of HR+/HER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer

  5. Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

    Recruiting Phase 2 GBG Forschungs Started 2024Primary completion 2028-12 NCT06201234

    olaparib FDA EUelacestrant

    …e Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1/2 Mutations

    BRCA1/2 mutationHormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation

  6. Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

    Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

    elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

    Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

    PIK3CA activating mutationBreast Cancer, Metastatic Breast Cancer

  7. Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

    Recruiting Phase 2 Northwestern University Started 2023Primary completion 2028-07 NCT06062498

    elacestrant FDA EUpalbociclibabemaciclib FDAribociclib

    Patients must have a confirmed ESR1 mutation.

    ESR1 mutationEstrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer

  8. A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

    Recruiting Phase 1 Stemline Therapeutics Started 2024Primary completion 2027-10 NCT06638307

    MEN2312elacestrant

    Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.

    PIK3CA activating mutationAdvanced Breast Cancer

  9. Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

    Active, not recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2024Primary completion 2026-11 NCT06691035

    elacestrant FDA EUDC1 native/mutated ESR1

    Participants must have Presence of an ESR1 mutation detected via tissue based or blood based (ctDNA) genomic profiling.

    ESR1 mutationBreast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer