drugset / Trial / NCT04385563
A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the efficacy,safety and immunogenicity of TQ-B211 plus docetaxel versus Herceptin® plus docetaxel in Patients with HER2-positive metastatic breast cancer.Trastuzumab plus docetaxel was chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC population in China.
Timeline
- Start
- 2018-11-11
- Primary completion
- 2021-02
- Completion
- 2021-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TQ-B211 | Unknown | 6 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |