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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 3 of 3 sitesv3 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 3 · Start date changed from estimate of Mar 2023 to Mar 30, 2023v2 Show 2 more changesShow less
    • Study sites: 2 to 3
    • Start date changed from estimate of Mar 2023 to Mar 30, 2023
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05780567
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Breast Cancer
Enrollment 1,946 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov