Inclusion Criteria

INCLUSION

To be eligible, volunteers must:

- Have stage IV carcinoma of the breast that has been microscopically confirmed

- Be age > 18

- Be fully active or ambulatory with symptoms but able to do light work

- Have a life expectancy of > 16 weeks

- Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis,
spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin C or
nitrosureas) and > 2 weeks from prior hormonal therapy

- Have had one or less prior regimens for metastatic disease

- Have measurable (bidimensionally) or evaluable disease that is in an area that has
not been radiated

EXCLUSION

Patients are not eligible if they:

- Have rapidly progressing liver or lung metastases or uncontrolled central nervous
system metastases

- Are medically unstable

- Are pregnant, nursing or unwilling to employ adequate contraception

- Have pre-existing clinically significant peripheral neuropathy except for
abnormalities due to cancer

- Have psychological, familial, sociological or geographical conditions that do not
permit weekly medical follow-up and compliance with the study protocol

- Have hypersensitivity to E. Coli-derived proteins, Filgrastim, or any of its
components

- Have had prior therapy with Navelbine