PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER

Inclusion Criteria

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