drugset / Trial / NCT00490646

A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

NCT00490646

Phase 2 Completed 50 enrolled R-Pharm
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.

Timeline

Start
2008-02
Primary completion
2011-06
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 100 mg/m2 Intravenous
Subject Ixabepilone Small molecule 40 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications