S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: filgrastim; trastuzumab; docetaxel; vinorelbine
Intervention MeSH terms: Docetaxel; Trastuzumab; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate
      tumor cells and either kill them or deliver tumor-killing substances to them without harming
      normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune
      system recover from the side effects of chemotherapy.

      PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel,
      vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
    

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