Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients (Beverly1)

This is an interventional treatment trial for Breast Cancer focused on measuring inflammatory breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer, HER2-negative breast cancer Read More

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