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

Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer

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.

Inclusion Criteria:

• Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
• Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
• Measurable disease
• Left Ventricular Ejection Fraction (LVEF) ≥50%

Exclusion Criteria:

• Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
• Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
• Neuropathy > Grade 1
• Significant cardiovascular disease
• Any brain metastases