drugset / Trial / NCT03135171

Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab

NCT03135171

Phase 1 Completed 11 enrolled University of Michigan Rogel Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal in this Phase 1 dose-escalation trial of the anti-IL-6R monoclonal antibody tocilizumab in combination with trastuzumab and pertuzumab in subjects with metastatic HER2 positive breast cancer is to determine the safety, tolerability and recommended Phase 2 dose of tocilizumab given with trastuzumab and pertuzumab every 3 weeks.

Timeline

Start
2017-07-26
Primary completion
2020-03-16
Completion
2020-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 4 mg/kg Intravenous
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Background Pertuzumab Monoclonal antibody 420 mg
Background Trastuzumab Monoclonal antibody 6 mg/kg

Indications