drugset / Trial / NCT05629949

A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer

NCT05629949

Phase 3 Completed 474 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

Timeline

Start
2020-04-29
Primary completion
2022-12-31
Completion
2023-04-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications