drugset / Trial / NCT04957212
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast cancer patients. Patients were stratified dynamically for random assignment to treatment with either Pertuzumab® (CinnaGen Co.) or originator pertuzumab, and received neoadjuvant TCHP regimen every 3- weeks.
Timeline
- Start
- 2018-08-11
- Primary completion
- 2020-05-27
- Completion
- 2020-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |