Clinical trial NCT00041067 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel, vinorelbine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        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