Clinical Trial

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

Active, Not Recruiting Phase 2/3
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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.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-21; most recent amendment 2024-10-28.
Status change: Recruiting → Active, Not Recruiting 2024-05-12
Trial Details
NCT Number NCT05426486
Lead Sponsor Caigang Liu
Conditions HER2-positive Breast Cancer
Enrollment 136 participants
Start Date 2022-05-23
Primary Completion 2025-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-30