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04/30/2025","primary_completion_date":" 04/30/2025","study_txt":" Completion: 06/30/2025","study_completion_date":" 06/30/2025","last_update_posted":"2024-01-25"},{"id":"10bc779c-5572-474d-b02c-73d1d2b1bbd1","acronym":"","url":"https://clinicaltrials.gov/study/NCT05365178","created_at":"2022-05-09T12:56:45.634Z","updated_at":"2024-07-02T16:35:24.870Z","phase":"Phase 3","brief_title":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer","source_id_and_acronym":"NCT05365178","lead_sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","biomarkers":" HER-2","pipe":" | ","alterations":" HR positive • HER-2 negative • PTEN mutation + HR positive","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • PTEN mutation + HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • Saitanxin (culmerciclib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 432","initiation":"Initiation: 07/01/2022","start_date":" 07/01/2022","primary_txt":" Primary completion: 06/01/2024","primary_completion_date":" 06/01/2024","study_txt":" Completion: 06/01/2026","study_completion_date":" 06/01/2026","last_update_posted":"2023-12-29"},{"id":"671af31b-ea72-43a1-a698-3450cef359b4","acronym":"","url":"https://clinicaltrials.gov/study/NCT05905341","created_at":"2023-06-15T17:08:34.937Z","updated_at":"2024-07-02T16:35:29.986Z","phase":"Phase 1","brief_title":"Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.","source_id_and_acronym":"NCT05905341","lead_sponsor":"Pfizer","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • PF-07224826"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 01/15/2024","start_date":" 01/15/2024","primary_txt":" Primary completion: 04/14/2026","primary_completion_date":" 04/14/2026","study_txt":" Completion: 04/13/2028","study_completion_date":" 04/13/2028","last_update_posted":"2023-11-08"},{"id":"2fc6e26e-1c88-4f2c-acb5-aa1c3f319425","acronym":"","url":"https://clinicaltrials.gov/study/NCT05304962","created_at":"2022-03-31T17:52:56.793Z","updated_at":"2024-07-02T16:35:33.621Z","phase":"Phase 1","brief_title":"First-in-Human Study of RGT-419B Alone and With Endocrine Therapy in Subjects With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer","source_id_and_acronym":"NCT05304962","lead_sponsor":"Regor Pharmaceuticals Inc.","biomarkers":" HER-2 • PIK3CA • 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negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • inixaciclib (NUV-422)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 09/01/2022","start_date":" 09/01/2022","primary_txt":" Primary completion: 06/01/2025","primary_completion_date":" 06/01/2025","study_txt":" Completion: 09/01/2026","study_completion_date":" 09/01/2026","last_update_posted":"2023-07-11"},{"id":"64ac45ca-111c-4c2c-a47a-1be6e6d73c40","acronym":"","url":"https://clinicaltrials.gov/study/NCT05780567","created_at":"2023-03-22T14:03:13.951Z","updated_at":"2024-07-02T16:35:49.881Z","phase":"Phase 3","brief_title":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer","source_id_and_acronym":"NCT05780567","lead_sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","biomarkers":" HER-2","pipe":" | ","alterations":" HR positive • HER-2 negative • HR positive + HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • HR positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e tamoxifen • letrozole • anastrozole • Saitanxin (culmerciclib)"],"overall_status":"Recruiting","enrollment":" Enrollment 1946","initiation":"Initiation: 03/30/2023","start_date":" 03/30/2023","primary_txt":" Primary completion: 12/01/2026","primary_completion_date":" 12/01/2026","study_txt":" Completion: 01/01/2027","study_completion_date":" 01/01/2027","last_update_posted":"2023-04-21"},{"id":"34480011-e1f9-46ba-a75f-ac6c6fd9bd0d","acronym":"","url":"https://clinicaltrials.gov/study/NCT05728541","created_at":"2023-02-15T18:02:59.911Z","updated_at":"2024-07-02T16:35:55.268Z","phase":"Phase 1","brief_title":"Dose Escalation and Expansion Study of SYH2043 in Patients With Advanced Malignant Tumors","source_id_and_acronym":"NCT05728541","lead_sponsor":"CSPC Ouyi Pharmaceutical Co., Ltd.","biomarkers":" HER-2 • ER","pipe":"","alterations":" ","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e SYH2043"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 367","initiation":"Initiation: 03/01/2023","start_date":" 03/01/2023","primary_txt":" Primary completion: 02/01/2026","primary_completion_date":" 02/01/2026","study_txt":" Completion: 03/01/2026","study_completion_date":" 03/01/2026","last_update_posted":"2023-02-17"},{"id":"09433bad-7c17-41a7-b1ca-4ac19bbc5a86","acronym":"STEAM","url":"https://clinicaltrials.gov/study/NCT03224104","created_at":"2021-01-18T15:54:47.667Z","updated_at":"2024-07-02T16:36:09.663Z","phase":"Phase 1","brief_title":"Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma","source_id_and_acronym":"NCT03224104 - STEAM","lead_sponsor":"European Organisation for 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Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors","source_id_and_acronym":"NCT00999401","lead_sponsor":"Cyclacel Pharmaceuticals, Inc.","biomarkers":" BRCA","pipe":" | ","alterations":" BRCA mutation","tags":["BRCA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e BRCA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e sapacitabine (CYC682) • seliciclib (CYC202)"],"overall_status":"Completed","enrollment":" Enrollment 103","initiation":"Initiation: 04/01/2009","start_date":" 04/01/2009","primary_txt":" Primary completion: 07/16/2019","primary_completion_date":" 07/16/2019","study_txt":" Completion: 08/13/2019","study_completion_date":" 08/13/2019","last_update_posted":"2021-12-22"},{"id":"9c28c66f-c3b4-4633-96d1-74a5ed78d628","acronym":"","url":"https://clinicaltrials.gov/study/NCT02942264","created_at":"2021-01-18T14:26:49.487Z","updated_at":"2024-07-02T16:36:23.846Z","phase":"Phase 2","brief_title":"Zotiraciclib (TG02) Plus Dose-Dense or 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01/31/2023","last_update_posted":"2021-03-15"},{"id":"7f62324a-e7d4-4136-ac70-9bf8a08201dd","acronym":"TQB3616-II-01","url":"https://clinicaltrials.gov/study/NCT04773418","created_at":"2021-02-26T12:55:13.627Z","updated_at":"2025-02-26T09:48:21.415Z","phase":"Phase 2","brief_title":"A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer","source_id_and_acronym":"NCT04773418 - TQB3616-II-01","lead_sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","biomarkers":" HER-2","pipe":" | ","alterations":" HR positive • HER-2 negative • HR positive + HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • HR positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • Saitanxin (culmerciclib)"],"overall_status":"Recruiting","enrollment":" Enrollment 120","initiation":"Initiation: 02/04/2021","start_date":" 02/04/2021","primary_txt":" Primary completion: 01/31/2023","primary_completion_date":" 01/31/2023","study_txt":" Completion: 01/31/2023","study_completion_date":" 01/31/2023","last_update_posted":"2021-02-26"},{"id":"0abd8fc1-b9bb-47ad-887a-ea2d0e5abad8","acronym":"","url":"https://clinicaltrials.gov/study/NCT03850873","created_at":"2021-01-18T19:00:47.644Z","updated_at":"2024-07-02T16:37:02.527Z","phase":"Phase 1","brief_title":"A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics","source_id_and_acronym":"NCT03850873","lead_sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","biomarkers":" HER-2 • ER","pipe":"","alterations":" ","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Saitanxin (culmerciclib)"],"overall_status":"Unknown status","enrollment":" Enrollment 30","initiation":"Initiation: 03/01/2019","start_date":" 03/01/2019","primary_txt":" Primary completion: 09/30/2020","primary_completion_date":" 09/30/2020","study_txt":" Completion: 09/30/2021","study_completion_date":" 09/30/2021","last_update_posted":"2019-02-22"}]