Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed\* adenocarcinoma of the breast
• * Incurable, locally advanced or metastatic disease
• * Primarily stage IV disease, but some inoperable stage III disease may be eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive doxorubicin or who has already received other therapy) NOTE: \*Patients with no available tissue for histologic confirmation but who have documentation of breast surgery and prior chemotherapy are eligible upon approval of the principal investigator
• Measurable disease
• No evidence of CNS metastases by brain MRI or contrast head CT scan
• * CNS metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female or male
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• At least 3 months
• Hematopoietic
• Granulocyte count at least 1,200/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there is clinical evidence of Gilbert's disease)
• AST and ALT no greater than 2.5 times ULN
• Renal
• Creatinine normal OR
• Creatinine clearance greater than 40 mL/min
• Other
• No poor medical risk due to other nonmalignant systemic disease
• No active uncontrolled infection
• No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater (unless neuropathy is clearly due to underlying breast cancer)
• No other concurrent serious medical illness
• No prior severe hypersensitivity reactions to agents containing Cremophor EL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• More than 4 weeks since prior filgrastim (G-CSF), pegfilgrastim, or thrombopoietin (or other platelet growth factors)
• No concurrent immunotherapy
• Chemotherapy
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No other concurrent chemotherapy for breast cancer
• Endocrine therapy
• More than 2 weeks since prior hormonal therapy
• No concurrent hormonal therapy
• Radiotherapy
• See Disease Characteristics
• No prior craniospinal radiation
• No prior total body irradiation
• More than 4 weeks since prior radiotherapy
• Surgery
• See Disease Characteristics
• Other
• No other concurrent investigational drugs
• No concurrent cytochrome p450 3A4 inhibitors, including any of the following:
• * Clarithromycin
• * Erythromycin
• * Troleandomycin
• * Delaviridine
• * Nelfinavir
• * Amprenavir
• * Ritonavir
• * Indinavir
• * Saquinavir
• * Lopinavir
• * Itraconazole
• * Ketoconazole
• * Fluconazole (\> 200 mg/day)
• * Voriconazole
• * Nefazodone
• * Fluvoxamine
• * Verapamil
• * Diltiazem
• * Amiodarone
• Concurrent bisphosphonates for bone metastases allowed