Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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