drugset / Trial / NCT01513083

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

NCT01513083

Phase 1 Completed 28 enrolled Hoffmann-La Roche
Parallel-groupOpen-labelTreatment

Summary

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Timeline

Start
2012-02
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab emtansine Other / unclassified Intravenous

Indications