Trial Information

Summary: A Neoadjuvant Study of AC Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer That is HER-2 Negative and Estrogen Receptor Negative

This study will evaluate the effectiveness of ixabepilone when given after doxorunicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy. The target sample size is 300 individuals.

Inclusion Criteria:

• Eligible women must have adenocarcinoma of breast that is .2cm, T2-3, N0-3 and M0
• Histologically confirmed primary invasive adenocarcinoma of the breast
• Breast Cancer must be ER and HER-2/neu negative
• No prior treatment for breast cancer excluding therapy for DCIS
• Karnofsky performance status of 80-100 LVEF .50% by echocardiogram or MUGA
• Adequate hematologic, hepatic and renal function

Exclusion Criteria:

• WOCBP unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
• Women who are pregnant or breastfeeding
• Inflammatory or metastatic breast cancer
• Unfit for breast and/or axillary surgery
• Evidence of baseline sensory or motor neuropathy
• Significant history of cardiovasular disease, serious intercurrent illness or infections including known HIV infection
• History of prior anthracycline therapy

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.