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

• Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
• Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
• Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
• Additional blood work will be performed once per week after the first two doses of CT-2103.
• The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

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