Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer

Inclusion Criteria:

* Patients must have stage IV, microscopically-confirmed carcinoma of the breast with histologic slides and/or blocks available for review.
* Patients must have relapse or progression while receiving, or within 12 months of having received, anthracycline-containing (doxorubicin or mitoxantrone) regimen as either adjuvant treatment or therapy for advanced breast cancer. Prior Taxol by 3- or 24-hour infusion is permitted. Patients who have received a maximum dose of anthracycline (greater than 450 mg/m2) are also eligible.
* Patients must have measurable (bidimensionally) or evaluable disease.
* Patients must be 18 or more years of age.
* Patients must have a Karnofsky Performance Status greater than or equal to 70% at screen and on the first day of treatment.
* Patients must have a life expectancy of more than 16 weeks.
* Prior irradiation is permitted, provided that prior irradiation does not exceed 25% of the estimated bone marrow volume and provided that measurable/evaluable disease exists outside the radiation field OR there must be histologic proof of progressive disease within a radiation field.
* Informed consent must be obtained prior to registration.
* Patients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy (more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior hormonal therapy.
* All patients must have appropriate central venous access.

Exclusion Criteria:

Patients are excludes if their:

* Granulocyte count is less than 1,500/mm3.
* Platelet count is less than 100,000/mm3.
* Hemoglobin is less than 9 gm/dl.
* Creatinine is greater than 2.0 mg/dl.
* Total bilirubin is greater than ULN (institutional upper limit of normal)..
* SGOT (AST) and/or SGPT (ALT) is greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN.

Patients are excluded if they are:

* In visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases.
* Medically unstable.
* Pregnant or lactating.

Patients are excluded if they have:

* Uncontrolled CNS disease.
* Pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer.
* Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
* Prior therapy with Navelbine.
* Sensitivity to E. Coli-derived proteins.