drugset / Trial / NCT00633464

Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer

NCT00633464

Phase 2 Completed 79 enrolled R-Pharm
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], Human Epidermal Growth Factor Receptor 2 \[HER2\] negative) locally advanced non-resectable and/or metastatic breast cancer

Timeline

Start
2008-06
Primary completion
2010-09
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Ixabepilone Small molecule 40 mg/m2 Intravenous