Clinical Trial

Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

Recruiting Phase 3
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Record status
This record was last updated February 2, 2024 (before its estimated October 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-12-13; most recent amendment 2024-01-31.
Status change: Not Yet Recruiting → Recruiting 2022-02-17
Trial Details
NCT Number NCT05159193
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions Breast Cancer
Enrollment 372 participants
Start Date 2021-12-20
Primary Completion 2024-10-30 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-02-02