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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

StatusRecruiting
PhasePhase 3
Started2021-12-20
View on ClinicalTrials.gov ↗
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.

Amendment history

2024-01-31
Study Status, Outcome Measures v2
Re-verified, no change to tracked fields
2022-02-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-10→2024-10-30
Completion date2028-01→2028-01-31
Start dateestimated 2021-12→confirmed 2021-12-20
Study sitesdetails revised at 1 of 1 site
2021-12-13
Original filing
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.
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