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
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
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
Inclusion Criteria:

 -  Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced
 non-resectable and/or metastatic breast cancer

 -  Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

 Exclusion Criteria:

 -  Tumors that are fluorescence in situ hybridization test (FISH) positive or
 immunohistochemistry (IHC) 3+

 -  Neuropathy > Grade 1

 -  Prior systemic therapy for metastatic disease