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

NCT06107790

Phase 3 Completed 570 enrolled Zhejiang Hisun Pharmaceutical Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Subject HS022 Unknown 6 mg/kg
Comparator Trastuzumab Monoclonal antibody 6 mg/kg
Background Vinorelbine Bitartrate Unknown 25 mg/m2 Intravenous