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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

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

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date changed from estimate of Jun 2024 to Jul 2, 2025v3
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting Enrollment target: estimated 428 to confirmed 432 · Study sites: 6 to 88 · Start date changed from estimate of Jun 2022 to Jul 1, 2022 · 3 morev2 Show 6 more changesShow less
    • Enrollment target: estimated 428 to confirmed 432
    • Study sites: 6 to 88
    • Start date changed from estimate of Jun 2022 to Jul 1, 2022
    • Eligibility criteria shortened, about 55 words
    • Secondary endpoints revised (8)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov