Last updated on November 2007

A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy


Are you eligible to participate in this study?

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

  • Conditions: Chemotherapy | Neutropenia | Breast Cancer
  • Age: Between 20 - 70 Years
  • Gender: Male or Female
  • Other:
    Signed informed consent obtained prior to inclusion in study
    Pathologically confirmed breast cancer, whose CBC has shown ever dropped unto 1,000
    to 3,000/mm3 in WBC count, or unto 500 to 1,500/mm3 in ANC count, on Day 8 or Day 15,
    whilst on Cycle 1 of current chemotherapy.
    Age 20 - 70 years
    Stage T 1-3, N 0-2, M0.
    ECOG performance status of < 2
    Chemotherapy regimen is restricted to one of the followings:
    (1)Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2(AC X 4cycles) or (2)Cyclophosphamide
    500 mg/m2 + Doxorubicin 50 mg/m2 + 5-FU 500 mg/m2 (CAF X 6 cycles) 7.Laboratory test
    results within 30 days prior to study entry:
    Hemoglobin 9.0 g/dL for men and 8.7 g/dL for women and platelet> 100,000/mm³ without
    the need for current, on-going use of erythropoietin or transfusion
    Normal liver function (GOT < 1.5 x ULN)
    Normal kidney function (Creatinine < 1.5 x ULN) and no dialysis. 8.Negative of
    mandatory pregnancy test for women subjects.

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

  • Women under pregnancy or with positive result from mandatory pregnancy test or in
    lactating; women of child-bearing potential must use adequate contraception
    Prior systemic therapy or radiotherapy for breast cancer
    Known hypersensitivity to bean products
    Serious medical or psychiatric illness that, in the opinion of the principal
    investigator, would interfere with the ability to adhere to study requirements.
    History of myocardial infraction or angina.
    Uncontrollable acute or chronic diseases, including hypertension or diabetes.
    Second malignancy or cancer metastasis
    HBV or HCV carrier
    WBC below 4000 or ANC below 2000 on D1 of Cycle 1
    Participation in investigational drug study within the past 30 days

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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