Clinical Trial

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Active, Not Recruiting Phase 3
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Summary
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-03-10; most recent amendment 2026-04-16.
Status change: Recruiting → Active, Not Recruiting 2026-04-16
Status change: Not Yet Recruiting → Recruiting 2023-04-19
Trial Details
NCT Number NCT05780567
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Breast Cancer
Enrollment 1,946 participants
Start Date 2023-03-30
Primary Completion 2026-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-17