Last updated on June 2013

Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

Are you eligible to participate in this study?

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

  • Conditions: Inflammatory Breast Cancer
  • Age: Between 20 - 75 Years
  • Gender: Female
  • Other:
    • Patients must have signed a written informed consent form prior to any study
    pecific procedures,
    20 years or older,
    Performance status < 2 (ECOG),
    Histologically confirmed inflammatory breast cancer T4d any N,
    hormonal Status known,
    no metastases according to the last TNM classification,
    adequate hematologic function :
    absolute neutrophil count ≥ 1 500/mm3
    Platelets ≥ 100 000/mm3
    Hemoglobin ≥ 9 g/dL
    adequate liver function :
    ASAT and ALAT < à 3 ULN
    Alkaline Phosphatase < 5 ULN
    Total bilirubin < 1,5 ULN, o
    adequate kidney function :
    creatinine < 1,5 x normal or creatinine Clearance ≥ 50ml/min (according to
    the cockcroft and Gault formula)
    Urine Dipstick for proteinuria < 2+ patients who have proteinuria ≥ 2 + on
    dipstick urinalysis at baseline should undergo a 24 hours urine collection
    and must demonstrate ≤ 1 g of protein in 24 hours,
    adequate coagulation and cardiac function :
    Prothrombin ratio ≥ 70 % and,
    Prothrombin time ≤ 1,5 upper limit of normal (ULN) within 7 days prior to
    Left Ventricular ejection fraction (LVEF) ≥ 55 %

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

  • Patients of childbearing potential with a positive pregnancy test (serum or urine)
    prior to enrollment
    Patients who are either not post-menopausal, or surgically sterile, not using
    "effective contraception" (the definition of "effective contraception" will be based
    on the judgment of the investigator)
    Patients who are pregnant or breastfeeding
    Patient considered socially or psychological unable to comply with the treatment and
    the required medial follow-up,
    Concurrent participation in another clinical trial or treatment with any other
    anticancer agent during the protocol specified period
    Patients unwilling or unable to sign and date an Ethics Committee (EC)/ Institutional
    Review Board (IRB)-approved patient informed consent form
    Patients unwilling or unable to comply with scheduled visits, treatment plans,
    laboratory tests, and other study procedures
    Non inflammatory breast cancer with lymphatic skin permeation, Metastases,
    Bilateral breast cancer
    Distant metastases (stage IV)
    History of another cancer other than adequately treated carcinoma in situ of the
    cervix uteri, basal or squamous cell skin cancer
    Prior anti tumor therapy (surgery, radiotherapy, chemotherapy, hormonal treatment and
    targeted therapy) except treatments given for carcinoma in situ of the cervix uteri,
    basal or squamous cell skin cancer
    History or evidence of inherited bleeding diathesis or coagulopathy,
    History of thrombotic disorders within the last 6 months prior to enrollment (i.e.
    cerebrovascular accident, transient ischemic attacks, subarachnoid hemorrhage),
    Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)with or
    without any anti-hypertensive medication ; patients with high initial blood pressure
    are eligible if entry criteria are met after initiation or adjustment of
    anti-hypertensive medication,
    Any of the following within 6 months prior to enrollment:
    myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft
    urgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically
    ignificant cardiac arrhythmias (grade 3-4)
    Severe resting dyspnea due to complications or oxygen dependency,
    Diabetic patient treated with oral anti-diabetics or insulin with an underlying
    cardiopathy at ultrasound,
    Any other severe acute illness such as active uncontrolled infections that would
    preclude the safe administration of study therapy at the time of the enrolment
    Other severe underlying medical conditions, which could impair the ability to
    participate in the study
    Major surgery, significant traumatic injury within 28 days prior to study treatment
    tart or anticipation of the need for major surgery during study treatment,
    Minor surgery, including insertion of an indwelling catheter, within 24 hours prior
    to the first bevacizumab infusion,
    Non-healing wound, active peptic ulcer or bone fracture,
    History of abdominal fistula, diagnosed with a trachea-oesophageal fistula or any
    grade 4 non gastro-intestinal fistula, gastrointestinal perforation or
    intra-abdominal abscess within 6 months of enrolment,

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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