Last updated on November 2005

Myocet Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Breast Cancer
  • Age: Between 18 - 70 Years
  • Gender: Female
  • Other:
    HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods:
    Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+
    it is needed a positive FISH test
    Female < 70yrs
    Histologically or cytologically proven breast cancer.
    Metastatic or locally advanced breast cancer (clinical stage: III-IV)
    Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by
    echocardiography with FEVS ≥50%
    Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total
    dose ≤450 mg/m2

You may not be eligible for this study if the following are true:

  • History of cardiopathy
    Severe hepatic and renal diseases
    Brain metastases as the only parameter of disease
    Contraindication to the use of corticosteroids as premedication
    Acute infectious diseases
    Insulin-dependent diabetes
    History of other cancers except for adequately treated basal cell skin cancer or in
    itu carcinoma of the cervix
    Concurrent treatment with any other cancer therapy

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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