drugset
drugset / Trial / NCT02419742

Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen

NCT02419742 ↗

Phase 4 Completed 110 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive or high risk node negative breast cancer participants with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (AC-TH Regimen) or a regimen consisting of docetaxel and carboplatin (TCH Regimen) in Indian population.

Timeline

Start
2015-08-18
Primary completion
2021-06-24
Completion
2021-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications

breast cancer