Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast
• * Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)
• * Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions
• Must meet 1 of the following conditions:
• * Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)
• * Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen
• * One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
• * Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed
• Bidimensionally measurable
• No clinical or radiographic evidence of brain or leptomeningeal disease
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Female
• Menopausal status:
• Not specified
• Performance status:
• Karnofsky 60-100% OR
• ECOG 0-2
• Life expectancy:
• At least 12 weeks
• Hematopoietic:
• Absolute neutrophil count at least 2,000/mm3
• Platelet count at least 100,000/mm3
• Hepatic:
• Bilirubin normal
• SGOT no greater than 2.5 times upper limit of normal
• Renal:
• Creatinine no greater than 2.0 mg/dL
• No uncontrolled hypercalcemia
• Cardiovascular:
• No myocardial infarction within the past 6 months
• No history of arrhythmia requiring treatment
• No heart block
• No clinical evidence of congestive heart failure
• No unstable angina (e.g., new onset, crescendo, or rest angina)
• Stable exertional angina allowed
• Other:
• No current symptomatic grade 2 or greater peripheral neuropathy
• No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)
• No serious infection
• No significant psychiatric disease that would preclude study
• No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior bone marrow or stem cell transplantation
• Chemotherapy:
• See Disease Characteristics
• At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
• No prior high-dose chemotherapy given with ablative intent
• No prior taxoids
• No other concurrent antineoplastic therapy
• Endocrine therapy:
• See Disease Characteristics
• Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed
• At least 1 week since prior hormonal therapy
• No concurrent corticosteroids except:
• * Prophylaxis or treatment for acute hypersensitivity reactions
• * Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent)
• Radiotherapy:
• At least 4 weeks since prior radiotherapy to major bone marrow areas
• No prior high-dose radiotherapy given with ablative intent
• No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response
• Surgery:
• See Disease Characteristics
• More than 2 weeks since prior surgery except simple biopsy or placement of venous access device
• Other:
• At least 4 weeks since prior investigational drugs
• Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed
• No concurrent ketoconazole
• No concurrent bisphosphonates unless initiated more than 3 months before randomization
• No concurrent experimental drug or therapy