Inclusion Criteria:

- Breast cancer, previously untreated Exclusion Criteria: - Active
infection requiring treatment with systemic (intravenous or oral) anti-infectives
(antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy
within the last 5 years, with the exception of surgically cured basal/squamous skin cell
carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ -
History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or
congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous
exposure to cytokines within two weeks prior - Concurrent use of other investigational
agents