drugset / Trial / NCT05283837

A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)

NCT05283837

Phase 3 Completed 268 enrolled Zydus Lifesciences Limited
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

EvaluationDrugModalityDoseRoute
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous

Indications