[{"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":"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":"7ba89d14-4615-45ff-b803-3622f020132c","acronym":"","url":"https://clinicaltrials.gov/study/NCT05375461","created_at":"2022-05-16T12:54:45.985Z","updated_at":"2024-07-02T16:36:10.407Z","phase":"Phase 3","brief_title":"TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail","source_id_and_acronym":"NCT05375461","lead_sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • HER-2 negative • ER positive + HER-2 negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • ER positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • Saitanxin (culmerciclib)"],"overall_status":"Recruiting","enrollment":" Enrollment 287","initiation":"Initiation: 03/18/2022","start_date":" 03/18/2022","primary_txt":" Primary completion: 12/01/2023","primary_completion_date":" 12/01/2023","study_txt":" Completion: 12/01/2023","study_completion_date":" 12/01/2023","last_update_posted":"2022-05-16"},{"id":"9ede2052-dcca-4922-b14c-3f70623bfbb4","acronym":"","url":"https://clinicaltrials.gov/study/NCT05139082","created_at":"2021-12-01T15:53:48.087Z","updated_at":"2024-07-02T16:36:20.025Z","phase":"Phase 1/2","brief_title":"Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors","source_id_and_acronym":"NCT05139082","lead_sponsor":"Peking University","biomarkers":" PD-L1","pipe":"","alterations":" ","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Andewei (benmelstobart) • Saitanxin (culmerciclib)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 60","initiation":"Initiation: 11/24/2021","start_date":" 11/24/2021","primary_txt":" Primary completion: 10/01/2023","primary_completion_date":" 10/01/2023","study_txt":" Completion: 10/01/2023","study_completion_date":" 10/01/2023","last_update_posted":"2021-12-01"},{"id":"239e840f-bfc9-429f-ae79-a5774d807790","acronym":"","url":"https://clinicaltrials.gov/study/NCT04796623","created_at":"2021-03-15T16:53:31.652Z","updated_at":"2024-07-02T16:36:33.330Z","phase":"Phase 2","brief_title":"A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer","source_id_and_acronym":"NCT04796623","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":"2021-03-15"},{"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"}]