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The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the tumor response using RECIST Criteria to determine the best overall response and response rate | For a maximum of 9 3-week cycles or until unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria | Every cycle | |
| To evaluate the duration of achieved responses | For a maximum of 9 3-week cycles or until unacceptable toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| To evaluate time to progression (TTP) | For a maximum of 9 3-week cycles or until unacceptable toxicity |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
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