drugset / Trial / NCT07093931
Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer
Phase 4
Not yet recruiting
468 enrolled
Shandong Cancer Hospital and Institute
Cancer Hospital Chinese Academy of Medical Science · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer. Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2027-08-01
- Completion
- 2030-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Lobaplatin | Small molecule | 30 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Background | Pertuzumab | Monoclonal antibody | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |