Breast Cancer Clinical Trial
Official title:
Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer. | |||
Secondary | To evaluate the side effects of CT-2103 in patients with metastatic breast cancer | |||
Secondary | to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months | |||
Secondary | to determine the time to progression and overall survival of patients treated with CT2103. |
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