drugset / Trial / NCT05283837
A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC.
Timeline
- Start
- 2022-09-26
- Primary completion
- 2023-09-06
- Completion
- 2023-09-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |