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A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 30, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint revised
    • Secondary endpoints revised (6)
    v4
  2. Trial status: Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 150 to 136
    • Study completion date: Dec 30, 2026 to Dec 30, 2028
    • Site details revised
    • Collaborators shortened, about 5 words
  3. Collaborators: 2 to 1v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer.
Trial Details
NCT Number NCT05426486
Lead Sponsor Caigang Liu
Conditions
(from sponsor)		 HER2-positive Breast Cancer
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov