Clinical Trial

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

Active, Not Recruiting Phase 3
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Summary
A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant injection (experimental group) or placebo capsule combined with fulvestrant (control group). A total of 428 subjects were required.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-05-06; most recent amendment 2026-01-04.
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-12-28
Trial Details
NCT Number NCT05365178
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions HR-positive, HER2-negative Breast Neoplasms
Enrollment 432 participants
Start Date 2022-07-01
Primary Completion 2025-07-02 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-07