BMS-247550 in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer. Determine the safety of this drug in these patients. Determine the duration of response, time to progression, and survival of patients treated with this drug. 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.

Official Title
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A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast carcinoma Stage IV or recurrent disease with distant metastases Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease Progressed during therapy or within 4 months of last dose OR Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only Received prior anthracycline therapy Bidimensionally measurable metastatic lesion Bony lesions not considered measurable No known brain metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Sex: Female Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count greater than 125,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: No grade 2 or greater neuropathy (motor or sensory) No uncontrolled infection or other medical illness that would preclude study No psychiatric disorder or other condition that would preclude study No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity to agents containing Cremophor EL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 24 hours since prior growth factor No concurrent trastuzumab (Herceptin) No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except hormone replacement therapy) Radiotherapy: At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine) No prior radiotherapy to target lesion if only measurable lesion No concurrent therapeutic radiotherapy Surgery: At least 1 week since prior minor surgery At least 3 weeks since prior major surgery Recovered from prior surgery Other: Recovered from all prior treatment-related toxic effects (alopecia allowed) No other concurrent experimental anticancer medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer