Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease * Age greater than 18 years * At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy * HER2-negative breast cancer * Up to one prior chemotherapy for advanced or metastatic disease * ECOG performance status 0-1 * Life expectancy \> 12 weeks * Adequate liver and bone marrow function: AST \< 2.5 x ULN; Bilirubin \< 1.5 x ULN; ANC \> 1,500/ul; platelet count \> 100,000/ul; normal PT and PTT * At least 2 weeks since prior radiation and recovered from treatment-related toxicity Exclusion Criteria: * Prior taxanes for treatment of metastatic disease * Pregnant of breast-feeding women * HER2-positive breast cancer * More than 1 prior chemotherapy regimen for metastatic disease * Untreated brain metastases * Concurrent radiotherapy or investigational drug * Prior bone marrow or stem cell transplant * History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer * Uncontrolled infection * Active bleeding, or history of bleeding requiring transfusion * Active cardiac disease * Serious medical or psychiatric illness