Statement: Patients with HER2 positive breast tumors are eligible for the primary trial, but excluded from the secondary trial.
Primary_evidence: Inclusion Criteria:   Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.   Tumors over-expressing Her-2   Candidate for treatment with docetaxel/trastuzumab Exclusion Criteria:   Histology of inflammatory carcinoma   AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
Secondary_evidence: DISEASE CHARACTERISTICS:   Histologically confirmed stage IV breast cancer   Metastasis to the ipsilateral supraclavicular lymph nodes allowed   HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting   No effusions or ascites as only sites of disease   No primary or metastatic brain or central nervous system tumor   Hormone receptor status:   Not specified   PATIENT CHARACTERISTICS:   Age:   18 and over   Sex:   Female   Menopausal status:   Not specified Performance status:   Zubrod 0-2   Life expectancy:   Not specified   Hematopoietic:   Absolute neutrophil count at least 1,500/mm^3   Platelet count at least 100,000/mm^3   Hepatic:   Bilirubin normal   aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)   Alkaline phosphatase no greater than 2.5 times ULN   Renal:   Not specified   Cardiovascular:   left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)   No clinical evidence or history of cardiomyopathy   Other:   No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer   No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80   No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission   No known sensitivity to E. coli-derived proteins   Not pregnant or nursing   Negative pregnancy test   Fertile patients must use effective contraception   PRIOR CONCURRENT THERAPY:   Biologic therapy:   Not specified   Chemotherapy:   At least 6 months since prior chemotherapy   Prior anthracycline as adjuvant therapy allowed   No prior cumulative dose of doxorubicin more than 360 mg/m^2   No prior cumulative dose of epirubicin more than 720 mg/m^2   No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease   No prior docetaxel   No prior vinorelbine   Prior paclitaxel allowed   Endocrine therapy:   Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed   No concurrent hormonal therapy   Radiotherapy:   At least 3 weeks since prior radiotherapy   Surgery:   At least 2 weeks since prior surgery and recovered