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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068729 | Registry Identifier | PDQ (Physician Data Query) | |
| BMS-CA163-009 | |||
| CPMC-IRB-13916 | |||
| NCI-G01-1967 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic breast carcinoma
Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease
Received prior anthracycline therapy
Bidimensionally measurable metastatic lesion
No known brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford A. Hudis, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States | ||
| Herbert Irving Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
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| New York |
| New York |
| 10032 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |