Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed inflammatory breast cancer, meeting 1 of the following staging criteria:
• •* T4d, any N (AJCC stage IIIB or IIIC)
• •* Gustave-Roussy Institute (IGR) classification Poussee evolutirie (PEV; measures tumor growth over time) 2
• •* PEV 2: tumor with underlying breast tissue, especially skin, that is affected by subacute inflammation and edema involving \< ½ of breast surface
• •* IGR classification PEV 3
• •* PEV 3: acute or subacute inflammation and edema involving \> ½ of breast surface
• •* Biopsy-confirmed presence of tumor embolism in surface lymph nodes
• •HER2-negative (HER2 0 or 1+, or HER2 2+ by IHC if FISH-negative allowed)
• •No metastatic disease
• •No non-inflammatory breast cancer with edema, ulceration, or satellite skin nodules
• •No bilateral breast cancer
• •Hormone receptor status known
• •PATIENT CHARACTERISTICS:
• •Any menopausal status allowed
• •WHO performance status 0-2
• •Life expectancy ≥3 months
• •LVEF normal by ECHO
• •ANC \>1.5 x 10\^9/L
• •Platelet count \>100 x 10\^9/L
• •INR ≤1.5 (except for patients on prophylactic anticoagulants)
• •aPTT ≤1.5 times upper limit of normal (ULN)
• •Total bilirubin normal
• •SGOT and SGPT ≤1.25 times ULN
• •Alkaline phosphatase ≤2.5 times ULN
• •Creatinine clearance ≥60 mL/min
• •Proteinuria \<2+ or 24-hour urine protein ≤1 g
• •No unhealed wound, stomach ulcer, or bone fracture
• •No history of thrombotic or hemorrhagic disorders
• •No significant cardiovascular disease including the following:
• •* Cerebrovascular accident within the past 6 months
• •* Unstable angina
• •* Cardiac failure
• •* Myocardial infarction
• •* Arrhythmia requiring treatment
• •No uncontrolled hypertension (i.e., systolic BP \>150 mm Hg and/or diastolic BP \>100 mm Hg)
• •No other active infection or serious illness that would preclude patient from receiving study treatment
• •No hypersensitivity to any active products or excipients of study drugs
• •Not pregnant or nursing
• •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• •No social or psychologic reasons that would prevent study compliance or follow-up
• •No patients who are incarcerated or on probation
• •PRIOR CONCURRENT THERAPY:
• •No prior chemotherapy, radiotherapy, or hormonal therapy for this disease
• •More than 4 weeks since prior surgery (diagnostic biopsy or installation of implant allowed)
• •More than 10 days since prior chronic non-inflammatory steroids (e.g., acetylsalicylic acid \>325 mg/day) or platelet anticoagulation treatment (e.g., dipyridamole, ticlopidine, clodiprogel, cilostazol)
• •More than 10 days since prior oral or parenteral anticoagulant or thrombolytic drugs (preventative thrombolytic drugs allowed)
• •No concurrent participation in another experimental clinical trial