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Elacestrant

Phase 3

ER+ / HER2- Advanced Breast Cancer | Small molecule | Oncology |GE HealthCare Technologies Inc.|Last Updated: Aug 10, 2026

Development status

Highest phase Phase 3 run by Stemline Therapeutics, Inc. (NCT06492616)
Phase scored for GEHCPhase 2
Registered trials 8 across 5 sponsors since May 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Elacestrant · 1 trial · 1 indication

Phase 2 1
NCT07753954Medical Imaging to Re-evaluate Elacestrant Clinical UsageER+ / HER2- Advanced Breast Cancer
NOT YET_RECRUITING160 Analytics
PHASE2NOT YET_RECRUITING
Medical Imaging to Re-evaluate Elacestrant Clinical Usage
ER+ / HER2- Advanced Breast Cancer
NCT07753954160
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Study Endpoints

Primary Endpoints

Progression-free survival in participants with ESR1-mut-nd
From first day of treatment until 6 months after first day of treatment

To determine the efficacy of elacestrant by 18F-FES-PET/CT result (homogeneous vs. heterogeneous) in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd.

Secondary Endpoints

Progression-Free Survival (PFS) by central review as per (Response Evaluation Criteria In Solid Tumors) RECIST v1.143/ PET Response Criteria In Solid Tumours (PERCIST)
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)
Objective Response Rate (ORR) by central review, defined as per RECIST v1.143/ PERCIST
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)
Overall Survival (OS), defined as time from the date of treatment start to the date of death from any cause.
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Elacestrant Treatment for ER-Positive, HER2-Negative Breast Cancer Without ESR1 MutationEXPERIMENTAL -

Interventions

NameTypeDescription
ElacestrantDRUGElacestrant is an orally available tetrahydronaphthalene compound that acts as selective oestrogen receptor alpha (ERα) antagonist with receptor degrading activity (e.g., selective oestrogen receptor degrader, SERD) and is being developed as a monotherapy agent and in combinations for the treatment of oestrogen receptor (ER) positive breast cancer.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age ≥ 18 years old 2. ECOG performance status ≤ 1 3. Must have histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease not amenable to therapy with curative intent or metastatic disease not amenable to curative therapy. 4...

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Competitive Landscape -Breast Cancer 396 trials (matched to "ER+ / HER2- Advanced Breast Cancer")

Top 20 of 82 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN45PHASE3Fulvestrant, Capivasertib, Trastuzumab deruxtecan, Dato-DXd, Durvalumab
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Sacituzumab tirumotecan, Patritumab Deruxtecan, Olaparib, Belzutifan
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Imlunestrant, LY4064809, LY4101174, LY3484356
BioNTech SE Sponsored ADRBNTX7PHASE3BNT323, Pumitamig, BNT326
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab govitecan
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Capecitabine, Letrozole, Ga-NeoB
Pfizer Inc.PFE32PHASE3Vepdegestrant, PF-07220060, Palbociclib, Tucatinib, Trastuzumab
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, BG-75202, BGB-21447, BG-68501
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, OP-3136
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab
Celcuity Inc.CELC3PHASE3Gedatolisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, RYZ101, BMS-986340, Nivolumab
BriaCell Therapeutics CorpBCTX1PHASE3SV-BR-1-GM
Incyte CorporationINCY4PHASE2Ruxolitinib, Axatilimab
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Alisertib
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen
Oncolytics Biotech Inc.ONCY1PHASE2Pelareorep
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