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

Completed · Phase 2

Conditions studied: Breast Cancer, Metastatic Breast Cancer

In brief

The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.

Key facts

Study ID

NCT00148707

Run by

Dana-Farber Cancer Institute

People needed

45

Starts

2004-10-01

Expected to finish

2007-09-01

Last updated by the study team

2007-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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