15 recruiting, 3 active not recruiting, 3 not yet recruiting, 3 terminated. 25 Phase 2, 8 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 25 | Recruiting 15, Active not recruiting 3, Not yet recruiting 3, Terminated 3, Withdrawn 1 |
| Phase 1 | 8 | Recruiting 4, Terminated 2, Active not recruiting 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer Biospecimen Collection, Computed Tomography, Elacestrant - Advanced Endometrial Carcinoma, Metastatic Endometrial Carcinoma | Phase 2 | Not yet recruiting | Jonsson Comprehensive Cancer Center | 50 | 2026-12-18 | 2026-06-09 |
| Medical Imaging to Re-evaluate Elacestrant Clinical Usage Elacestrant - ER+ / HER2- Advanced Breast Cancer | Phase 2 | Not yet recruiting | Jules Bordet Institute | 160 | 2026-09-13 | 2026-08-10 |
| A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer Elacestrant - Breast Cancer | Phase 2 | Recruiting | Stemline Therapeutics, Inc. | 70 | 2026-08-18 | 2026-10-13 |
| Elacestrant in Advanced Triple Positive Breast Cancer Elacestrant, Trastuzumab, Pertuzumab - ER Positive, HER2 Positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | NYU Langone Health | 50 | 2026-05-13 | 2026-05-28 |
| Elacestrant and Exemestane for Patients With Pretreated HR+/HER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE) elacestrant and exemestane - Breast Cancer | Phase 2 | Recruiting | European Institute of Oncology | 26 | 2026-05-11 | 2026-05-14 |
| Ph 2 Elacestrant in ER Positive Uterine Sarcomas Elacestrant - Uterine Sarcoma, Uterine Leiomyosarcoma | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 30 | 2026-03-25 | 2026-05-22 |
| PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) Capecitabine, Elacestrant - Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | Kristina A. Fanucci | 297 | 2026-01-16 | 2026-08-26 |
| 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 Elacestrant, Trastuzumab Deruxtecan - Metastatic Breast Cancer, HER2 Low Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | Kristina A. Fanucci | 65 | 2025-11-17 | 2026-06-10 |
| A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer Elacestrant, Leuprorelin - Breast Cancer | Phase 2 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 140 | 2025-10-06 | 2025-12-01 |
| A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer Abemaciclib, Elacestrant - Endometrial Cancer | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 75 | 2025-10-01 | 2026-07-16 |
| Circulating Tumor DNA Elacestrant - ER+ Breast Cancer | Phase 2 | Recruiting | Yale University | 50 | 2025-09-30 | 2026-09-21 |
| Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy Elacestrant, PULSAR - Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Phase 2 | Not yet recruiting | Azienda Ospedaliero-Universitaria Careggi | 21 | 2025-09-01 | 2025-06-05 |
| Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Olaparib + Elacestrant, Olaparib - Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer | Phase 2 | Recruiting | GBG Forschungs GmbH | 176 | 2024-12-13 | 2025-12-01 |
| DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment Tamoxifen, Exemestane, Letrozole - Ductal Carcinoma in Situ | Phase 2 | Recruiting | QuantumLeap Healthcare Collaborative | 400 | 2024-02-17 | 2026-10-26 |
| Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer elacestrant, palbociclib, abemaciclib, ribociclib - Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer | Phase 2 | Recruiting | Northwestern University | 174 | 2023-09-29 | 2026-09-04 |
| Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI - Breast Cancer, ER-positive Breast Cancer | Phase 2 | Active not recruiting | University of Miami | 24 | 2023-06-12 | 2026-01-13 |
| A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer Elacestrant, Onapristone - Breast Cancer | Phase 1 / Phase 2 | Withdrawn | Context Therapeutics Inc. | 2023-06-01 | 2025-04-22 | |
| ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study Elacestrant - Metastatic Breast Cancer | Phase 2 | Active not recruiting | Stemline Therapeutics, Inc. | 61 | 2023-05-19 | 2026-05-07 |
| Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer Elacestrant, Triptorelin, Tamoxifen 20 mg - Breast Cancer, HER2-negative Breast Cancer | Phase 2 | Recruiting | SOLTI Breast Cancer Research Group | 96 | 2023-02-03 | 2026-04-24 |
| Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Elacestrant, Alpelisib, Everolimus - Breast Cancer, Metastatic Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Stemline Therapeutics, Inc. | 435 | 2023-01-24 | 2026-06-12 |
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Breast Neoplasms (17) · Endometrial Neoplasms (2) · Adenosarcoma of the uterus (1) · Brain Diseases (1) · Brain Neoplasms (1) · Breast Diseases (1) · Carcinoma, Intraductal, Noninfiltrating (1) · Central Nervous System Diseases (1) · Central Nervous System Neoplasms (1) · Hot Flashes (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Neoplasms by Site (1) · Perivascular Epithelioid Cell Neoplasms (1) · Recurrence (1)
Stemline Therapeutics, Inc. (4) · Context Therapeutics Inc. (2) · Kristina A. Fanucci (2) · Azienda Ospedaliero-Universitaria Careggi (1) · Criterium, Inc. (1) · Dana-Farber Cancer Institute (1) · Ellipses Pharma (1) · European Institute of Oncology (1) · GBG Forschungs GmbH (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Jonsson Comprehensive Cancer Center (1) · Jules Bordet Institute (1) · Memorial Sloan Kettering Cancer Center (1) · NYU Langone Health (1) · Northwestern University (1)
United States (18) · Italy (4) · Spain (4) · France (3) · United Kingdom (3) · Belgium (2) · Brazil (2) · Germany (2) · South Korea (2) · Turkey (Türkiye) (2) · Argentina (1) · Australia (1) · Bulgaria (1) · Georgia (1) · Greece (1)
Kristina Fanucci, MD (2) · Douglas K Marks, MD (1) · Frances Valdes-Albini, MD (1) · Giuseppe Curigliano (1) · Jordyn Silverstein, MD (1) · Laura Esserman, MD, MBA (1) · Mariya Rozenblit, MD (1) · Martine Piccart, MD, PhD (1) · Peter Kabos, MD (1) · Sibylle Loibl, MD, PhD (1) · Sminu Bose, MD (1) · Suzanne George, MD (1)
2025 (2), P30CA060553 (1)