drugset / Trial / NCT05159193
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
Phase 3
Recruiting
372 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CSPC Ouyi Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2024-10-30
- Completion
- 2028-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 90 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |