An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer
Disease progression following prior adjuvant chemotherapy (no disease progression during
treatment with prior doxorubicin) Bidimensionally measurable disease Prior radiotherapy
allowed if disease completely outside radiation port or histologic evidence of measured
area indicating malignancy and not radiation fibrosis No CNS metastases Brain metastases
previously treated with radiotherapy or surgical excision allowed if no evidence of
residual metastases on brain CT or MRI Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Premenopausal or
postmenopausal Performance status: ECOG 0-1 Life expectancy: Greater than 16 weeks
Hematopoietic: WBC at least 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin
greater than 9 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times
upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Not
specified Cardiovascular: No symptomatic New York Heart Association class II or greater
congestive heart failure No significant arrhythmia requiring drug therapy No myocardial
infarction within the past 6 months No uncontrolled cardiac disease or unstable angina
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix No preexisting clinically significant peripheral
neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel) No
unstable, preexisting medical condition No serious active infection No other underlying
medical, psychological, familial, sociologic, or geographic condition that would preclude
study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior hematopoietic
growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 7
days since prior platelet transfusion Chemotherapy: See Disease Characteristics No prior
vinca alkaloids (including vinorelbine or docetaxel) No other concurrent antineoplastic
agents Endocrine therapy: No concurrent anticancer hormonal agents Radiotherapy: See
Disease Characteristics No concurrent palliative radiotherapy Surgery: See Disease
Characteristics Other: No other concurrent investigational drug or device