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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Drug: CT-2103 (Xyotax)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CT-2103 (Xyotax)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the side effects of CT-2103 in patients with metastatic breast cancer |  |  | 
| to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months |  |  | 
| to determine the time to progression and overall survival of patients treated with CT2103. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, HER2-negative Breast Cancer, CT-2103, Xyotax