drugset / Trial / NCT04185649
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
Timeline
- Start
- 2018-07-01
- Primary completion
- 2020-07-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT8001 | Monoclonal antibody | 3.6 mg/kg | Intravenous |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Lapatinib | Small molecule | 1250 mg | Oral |