[{"id":"21be25ed-db5c-4f88-af53-6dabef3b154a","acronym":"SUMIT-ELA","url":"https://clinicaltrials.gov/study/NCT05963997","created_at":"2023-07-27T17:09:07.832Z","updated_at":"2025-02-25T13:41:37.681Z","phase":"Phase 1/2","brief_title":"A Study of Samuraciclib and Elacestrant in Participants with Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer","source_id_and_acronym":"NCT05963997 - SUMIT-ELA","lead_sponsor":"Carrick Therapeutics Limited","biomarkers":" HER-2 • ER • TP53 • CDK4","pipe":" | ","alterations":" TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation","tags":["HER-2 • ER • TP53 • CDK4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant) • samuraciclib (CT7001)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 49","initiation":"Initiation: 10/09/2023","start_date":" 10/09/2023","primary_txt":" Primary completion: 12/23/2025","primary_completion_date":" 12/23/2025","study_txt":" Completion: 12/23/2025","study_completion_date":" 12/23/2025","last_update_posted":"2025-02-21"},{"id":"98d3d9bc-9e64-4b61-be85-59f415cfe1f1","acronym":"","url":"https://clinicaltrials.gov/study/NCT05573126","created_at":"2022-10-10T14:05:29.537Z","updated_at":"2025-02-25T13:41:17.825Z","phase":"Phase 1/2","brief_title":"Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer","source_id_and_acronym":"NCT05573126","lead_sponsor":"Ellipses Pharma","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus • Orserdu (elacestrant) • vosilasarm (EP0062)"],"overall_status":"Recruiting","enrollment":" Enrollment 60","initiation":"Initiation: 01/11/2023","start_date":" 01/11/2023","primary_txt":" Primary completion: 11/01/2025","primary_completion_date":" 11/01/2025","study_txt":" Completion: 11/01/2026","study_completion_date":" 11/01/2026","last_update_posted":"2025-02-21"},{"id":"accc8beb-5a40-4334-a4ae-f00e0d7cc772","acronym":"ELEVATE","url":"https://clinicaltrials.gov/study/NCT05563220","created_at":"2022-10-03T15:56:32.608Z","updated_at":"2025-02-25T14:17:18.649Z","phase":"Phase 1/2","brief_title":"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer","source_id_and_acronym":"NCT05563220 - ELEVATE","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER • PIK3CA • CDK4","pipe":" | ","alterations":" PIK3CA mutation","tags":["HER-2 • ER • PIK3CA • CDK4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 01/24/2023","start_date":" 01/24/2023","primary_txt":" Primary completion: 12/27/2026","primary_completion_date":" 12/27/2026","study_txt":" Completion: 12/28/2028","study_completion_date":" 12/28/2028","last_update_posted":"2025-02-18"},{"id":"a22b0db3-f6b3-489e-b362-7e9a7131a6f7","acronym":"ELECTRA","url":"https://clinicaltrials.gov/study/NCT05386108","created_at":"2022-05-23T15:53:51.405Z","updated_at":"2025-02-25T15:27:22.960Z","phase":"Phase 1/2","brief_title":"Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer","source_id_and_acronym":"NCT05386108 - ELECTRA","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" ER positive • HER-2 negative • HER-2 negative + ER positive","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • HER-2 negative + ER positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Verzenio (abemaciclib) • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 68","initiation":"Initiation: 08/31/2022","start_date":" 08/31/2022","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2025-02-11"},{"id":"96089508-6422-493f-82c5-12ed65ed1d61","acronym":"ELCIN","url":"https://clinicaltrials.gov/study/NCT05596409","created_at":"2022-10-27T15:58:31.639Z","updated_at":"2025-02-25T16:33:10.407Z","phase":"Phase 2","brief_title":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study","source_id_and_acronym":"NCT05596409 - ELCIN","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER","pipe":"","alterations":" ","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 60","initiation":"Initiation: 05/19/2023","start_date":" 05/19/2023","primary_txt":" Primary completion: 02/01/2025","primary_completion_date":" 02/01/2025","study_txt":" Completion: 08/01/2025","study_completion_date":" 08/01/2025","last_update_posted":"2025-02-07"},{"id":"348b6bee-e334-487c-b8b5-38e99c466308","acronym":"ADELA","url":"https://clinicaltrials.gov/study/NCT06382948","created_at":"2024-04-24T17:32:40.686Z","updated_at":"2024-07-02T16:35:07.380Z","phase":"Phase 3","brief_title":"Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.","source_id_and_acronym":"NCT06382948 - ADELA","lead_sponsor":"MedSIR","biomarkers":" HER-2 • ER • CDK4","pipe":" | ","alterations":" HER-2 mutation • ER mutation • ESR1 mutation • CDK4 mutation","tags":["HER-2 • ER • CDK4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 mutation • ER mutation • ESR1 mutation • CDK4 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus • Orserdu (elacestrant)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 240","initiation":"Initiation: 06/01/2024","start_date":" 06/01/2024","primary_txt":" Primary completion: 09/01/2027","primary_completion_date":" 09/01/2027","study_txt":" Completion: 04/01/2028","study_completion_date":" 04/01/2028","last_update_posted":"2024-04-26"},{"id":"91338d43-12ef-47bf-a692-0601c4e95ab1","acronym":"EMERALD","url":"https://clinicaltrials.gov/study/NCT03778931","created_at":"2021-01-18T18:41:31.336Z","updated_at":"2024-07-02T16:35:12.254Z","phase":"Phase 3","brief_title":"Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer","source_id_and_acronym":"NCT03778931 - EMERALD","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER","pipe":"","alterations":" ","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • letrozole • anastrozole • exemestane • Orserdu (elacestrant)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 478","initiation":"Initiation: 05/10/2019","start_date":" 05/10/2019","primary_txt":" Primary completion: 08/24/2021","primary_completion_date":" 08/24/2021","study_txt":" Completion: 08/01/2024","study_completion_date":" 08/01/2024","last_update_posted":"2024-03-29"},{"id":"5bc7659f-e2a6-4374-b158-c59500d35edf","acronym":"","url":"https://clinicaltrials.gov/study/NCT06075953","created_at":"2023-11-28T20:16:35.287Z","updated_at":"2024-07-02T16:35:12.554Z","phase":"Phase 2","brief_title":"DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment","source_id_and_acronym":"NCT06075953","lead_sponsor":"QuantumLeap Healthcare Collaborative","biomarkers":" HER-2","pipe":" | ","alterations":" HR positive","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 02/14/2024","start_date":" 02/14/2024","primary_txt":" Primary completion: 11/01/2028","primary_completion_date":" 11/01/2028","study_txt":" Completion: 11/01/2033","study_completion_date":" 11/01/2033","last_update_posted":"2024-03-27"},{"id":"774e2276-9e3e-4c25-a260-4a11c73a7ed3","acronym":"SOLTI-2104","url":"https://clinicaltrials.gov/study/NCT05982093","created_at":"2023-08-08T14:08:42.597Z","updated_at":"2024-07-02T16:35:19.531Z","phase":"Phase 2","brief_title":"Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer","source_id_and_acronym":"NCT05982093 - SOLTI-2104","lead_sponsor":"SOLTI Breast Cancer Research Group","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" ER positive • HER-2 negative • HER-2 expression","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • HER-2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant) • triptorelin"],"overall_status":"Recruiting","enrollment":" Enrollment 48","initiation":"Initiation: 10/03/2023","start_date":" 10/03/2023","primary_txt":" Primary completion: 10/01/2024","primary_completion_date":" 10/01/2024","study_txt":" Completion: 01/01/2025","study_completion_date":" 01/01/2025","last_update_posted":"2024-02-13"},{"id":"a71dfb98-71e8-43d7-baba-9d5f54087356","acronym":"","url":"https://clinicaltrials.gov/study/NCT05512364","created_at":"2022-08-23T14:55:35.137Z","updated_at":"2024-07-02T16:35:22.428Z","phase":"Phase 3","brief_title":"Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)","source_id_and_acronym":"NCT05512364","lead_sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" ER positive • HER-2 negative • ER positive + HER-2 negative","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • ER positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 220","initiation":"Initiation: 12/15/2023","start_date":" 12/15/2023","primary_txt":" Primary completion: 07/01/2028","primary_completion_date":" 07/01/2028","study_txt":" Completion: 05/01/2030","study_completion_date":" 05/01/2030","last_update_posted":"2024-01-24"},{"id":"82fc4ba9-d2eb-44d9-885d-9012d52f5a8a","acronym":"ELEMENT","url":"https://clinicaltrials.gov/study/NCT06201234","created_at":"2024-01-11T22:20:22.017Z","updated_at":"2024-07-02T16:35:23.743Z","phase":"Phase 2","brief_title":"Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer","source_id_and_acronym":"NCT06201234 - ELEMENT","lead_sponsor":"German Breast Group","biomarkers":" HER-2 • BRCA1","pipe":" | ","alterations":" HER-2 negative • PALB2 mutation • PTEN mutation + HR positive","tags":["HER-2 • BRCA1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PALB2 mutation • PTEN mutation + HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Zejula (niraparib) • Orserdu (elacestrant)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 176","initiation":"Initiation: 03/31/2024","start_date":" 03/31/2024","primary_txt":" Primary completion: 03/31/2028","primary_completion_date":" 03/31/2028","study_txt":" Completion: 03/31/2028","study_completion_date":" 03/31/2028","last_update_posted":"2024-01-11"},{"id":"ebecf9c8-7521-4456-bb66-ff2f533a0378","acronym":"","url":"https://clinicaltrials.gov/study/NCT06062498","created_at":"2023-10-02T20:12:30.489Z","updated_at":"2024-07-02T16:35:35.109Z","phase":"Phase 2","brief_title":"Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer","source_id_and_acronym":"NCT06062498","lead_sponsor":"Northwestern University","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • HER-2 negative • ER mutation • ESR1 mutation","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • ER mutation • ESR1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Orserdu (elacestrant)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 174","initiation":"Initiation: 09/30/2023","start_date":" 09/30/2023","primary_txt":" Primary completion: 07/01/2024","primary_completion_date":" 07/01/2024","study_txt":" Completion: 07/01/2025","study_completion_date":" 07/01/2025","last_update_posted":"2023-10-02"},{"id":"41d8c22d-3b0f-482a-9636-981a31cd84cb","acronym":"","url":"https://clinicaltrials.gov/study/NCT05826964","created_at":"2023-04-24T14:04:07.490Z","updated_at":"2024-07-02T16:35:39.425Z","phase":"Phase 2","brief_title":"Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer","source_id_and_acronym":"NCT05826964","lead_sponsor":"University of Miami","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • everolimus • tamoxifen • capecitabine • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • anastrozole • exemestane • Orserdu (elacestrant) • Navelbine oral (vinorelbine tartrate oral)"],"overall_status":"Recruiting","enrollment":" Enrollment 500","initiation":"Initiation: 06/12/2023","start_date":" 06/12/2023","primary_txt":" Primary completion: 07/31/2026","primary_completion_date":" 07/31/2026","study_txt":" Completion: 07/31/2029","study_completion_date":" 07/31/2029","last_update_posted":"2023-08-21"},{"id":"56b05602-4bff-4f86-8590-347905fc7116","acronym":"Lilly-I3Y-US-I026","url":"https://clinicaltrials.gov/study/NCT04791384","created_at":"2021-03-10T12:54:58.991Z","updated_at":"2024-07-02T16:35:41.726Z","phase":"Phase 1/2","brief_title":"Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer","source_id_and_acronym":"NCT04791384 - Lilly-I3Y-US-I026","lead_sponsor":"Criterium, Inc.","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" ER positive + PGR positive","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive + PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Verzenio (abemaciclib) • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 44","initiation":"Initiation: 04/21/2022","start_date":" 04/21/2022","primary_txt":" Primary completion: 12/01/2024","primary_completion_date":" 12/01/2024","study_txt":" Completion: 01/01/2025","study_completion_date":" 01/01/2025","last_update_posted":"2023-07-27"},{"id":"068e98ca-b609-443c-b617-92e17feb845f","acronym":"ELONA","url":"https://clinicaltrials.gov/study/NCT05618613","created_at":"2022-11-16T18:56:49.734Z","updated_at":"2024-07-02T16:35:52.141Z","phase":"Phase 1b","brief_title":"Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer","source_id_and_acronym":"NCT05618613 - ELONA","lead_sponsor":"Context Therapeutics Inc.","biomarkers":" HER-2","pipe":"","alterations":" ","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant) • Apristor (onapristone XR)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 67","initiation":"Initiation: 12/02/2022","start_date":" 12/02/2022","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 04/30/2026","study_completion_date":" 04/30/2026","last_update_posted":"2023-03-28"},{"id":"22aafbd8-3de1-4972-a79b-76ff923785ec","acronym":"ELIPSE","url":"https://clinicaltrials.gov/study/NCT04797728","created_at":"2021-03-15T15:53:41.485Z","updated_at":"2024-07-02T16:36:01.820Z","phase":"Phase 1","brief_title":"Elacestrant in Preoperative Setting, a Window of Opportunity Study","source_id_and_acronym":"NCT04797728 - ELIPSE","lead_sponsor":"SOLTI Breast Cancer Research Group","biomarkers":" HER-2 • ER • PIK3CA • PTTG1 • RRM2 • CDC20 • CEP55 • UBE2C","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • ER • PIK3CA • PTTG1 • RRM2 • CDC20 • CEP55 • UBE2C"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant)"],"overall_status":"Completed","enrollment":" Enrollment 23","initiation":"Initiation: 02/09/2021","start_date":" 02/09/2021","primary_txt":" Primary completion: 02/08/2022","primary_completion_date":" 02/08/2022","study_txt":" Completion: 02/25/2022","study_completion_date":" 02/25/2022","last_update_posted":"2022-10-26"},{"id":"df80d2bf-580c-47c6-b8a9-a082803be8cb","acronym":"","url":"https://clinicaltrials.gov/study/NCT02650817","created_at":"2021-01-18T12:54:20.282Z","updated_at":"2024-07-02T16:36:05.205Z","phase":"Phase 1","brief_title":"Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer","source_id_and_acronym":"NCT02650817","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • HER-2 negative • EGFR positive • ER expression","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • EGFR positive • ER expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Orserdu (elacestrant)"],"overall_status":"Completed","enrollment":" Enrollment 16","initiation":"Initiation: 04/01/2016","start_date":" 04/01/2016","primary_txt":" Primary completion: 08/30/2018","primary_completion_date":" 08/30/2018","study_txt":" Completion: 10/18/2019","study_completion_date":" 10/18/2019","last_update_posted":"2022-08-18"}]