drugset / Trial / NCT05720026
Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor \> 2 cm.
Timeline
- Start
- 2023-01-09
- Primary completion
- 2025-08-29
- Completion
- 2026-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | SYSA1901 | Unknown | 420 mg | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |