[{"id":"306f2837-4ae2-43cc-8471-5706f09281e5","acronym":"ELAINE 3","url":"https://clinicaltrials.gov/study/NCT05696626","created_at":"2023-01-25T16:59:42.976Z","updated_at":"2025-02-25T12:38:31.246Z","phase":"Phase 3","brief_title":"Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation","source_id_and_acronym":"NCT05696626 - ELAINE 3","lead_sponsor":"Sermonix Pharmaceuticals Inc.","biomarkers":" ER","pipe":" | ","alterations":" ESR1 mutation","tags":["ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ESR1 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Verzenio (abemaciclib) • fulvestrant • Fablyn (lasofoxifene)"],"overall_status":"Recruiting","enrollment":" Enrollment 500","initiation":"Initiation: 10/31/2023","start_date":" 10/31/2023","primary_txt":" Primary completion: 04/01/2027","primary_completion_date":" 04/01/2027","study_txt":" Completion: 04/01/2028","study_completion_date":" 04/01/2028","last_update_posted":"2025-02-24"},{"id":"e2cd3260-cd72-4639-a5ac-6d252bb0c83c","acronym":"ELAINEII","url":"https://clinicaltrials.gov/study/NCT04432454","created_at":"2021-01-18T21:20:42.852Z","updated_at":"2025-02-25T14:51:49.300Z","phase":"Phase 2","brief_title":"Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","source_id_and_acronym":"NCT04432454 - ELAINEII","lead_sponsor":"Sermonix Pharmaceuticals Inc.","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 Verzenio (abemaciclib) • Fablyn (lasofoxifene)"],"overall_status":"Completed","enrollment":" Enrollment 29","initiation":"Initiation: 09/29/2020","start_date":" 09/29/2020","primary_txt":" Primary completion: 01/28/2025","primary_completion_date":" 01/28/2025","study_txt":" Completion: 01/28/2025","study_completion_date":" 01/28/2025","last_update_posted":"2025-02-13"},{"id":"8cf55ab0-20f6-44cb-8bda-ecaebf4b0cba","acronym":"I-SPY 2","url":"https://clinicaltrials.gov/study/NCT01042379","created_at":"2021-01-17T17:27:23.313Z","updated_at":"2025-02-25T12:25:36.876Z","phase":"Phase 2","brief_title":"I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","source_id_and_acronym":"NCT01042379 - I-SPY 2","lead_sponsor":"QuantumLeap Healthcare Collaborative","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • ER negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • ER negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • Zejula (niraparib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • Datroway (datopotamab deruxtecan-dlnk) • Ziihera (zanidatamab-hrii) • ganitumab (AMG 479) • amcenestrant (SAR439859) • anvatabart opadotin (JNJ-0683) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • vepdegestrant (ARV-471) • Cosela (trilaciclib) • Fablyn (lasofoxifene) • DAN-222 • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • rilvegostomig (AZD2936) • trebananib (AMG 386) • Kevzara (sarilumab) • Voyager-V1"],"overall_status":"Recruiting","enrollment":" Enrollment 5000","initiation":"Initiation: 03/01/2010","start_date":" 03/01/2010","primary_txt":" Primary completion: 12/01/2030","primary_completion_date":" 12/01/2030","study_txt":" Completion: 12/01/2031","study_completion_date":" 12/01/2031","last_update_posted":"2024-10-22"},{"id":"41c64d00-75dd-4fa2-9ce1-9e342496ddc1","acronym":"ELAINE 1","url":"https://clinicaltrials.gov/study/NCT03781063","created_at":"2021-01-18T18:42:03.161Z","updated_at":"2024-07-02T16:35:08.944Z","phase":"Phase 2","brief_title":"Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","source_id_and_acronym":"NCT03781063 - ELAINE 1","lead_sponsor":"Sermonix Pharmaceuticals Inc.","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" HER-2 negative • ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER L536Q • ER Y537C","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER L536Q • ER Y537C"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • Fablyn (lasofoxifene)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 100","initiation":"Initiation: 09/20/2019","start_date":" 09/20/2019","primary_txt":" Primary completion: 12/01/2024","primary_completion_date":" 12/01/2024","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2024-04-18"}]