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
A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Listed as NCT05365178, this PHASE3 trial focuses on HR-positive, HER2-negative Breast Neoplasms and remains ongoing. Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., it has been updated 7 times since 2022, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
7 versions recorded-
Feb 2026 — Present [monthly]
Active Not Recruiting PHASE3
-
Sep 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE3
-
Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE3
-
Sep 2024 — Aug 2025 [monthly]
Active Not Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
▶ Show 2 earlier versions
-
Jan 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
Status: Not Yet Recruiting → Active Not Recruiting
-
Jun 2022 — Jan 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Baoding, China , Beijing, China , Bengbu, China , Binzhou, China , Cangzhou, China , Changchun, China , Changde, China , Changsha, China , Changzhi, China , Changzhou, China and 53 more locations