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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |