drugset / Trial / NCT06107790
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety and Immunogenicity of Vinorelbine Bitartrate Injection in Combination With HS022 and Trastuzumab®.There were 2 parts. Part 1 needs 8 treatment cycles ( at least 24 weeks); Part2 needs 9 treatment cycles (at least 27 weeks).
Timeline
- Start
- 2018-05-16
- Primary completion
- 2022-01-28
- Completion
- 2022-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS022 | Unknown | 6 mg/kg | — |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Background | Vinorelbine Bitartrate | Unknown | 25 mg/m2 | Intravenous |