A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer

Exclusion Criteria

• •No prior therapy with bevacizumab, sorafenib or any other known VEGF inhibitors.
• •No known hypersensitivity to any component of the study drugs.
• •No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
• •No history or radiologic evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptominigeal involvement. A head CT or MRI must be obtained within 28 days prior to being registered for protocol therapy.
• •No other participation in another clinical drug study within 28 days prior to being registered for protocol therapy.
• •No known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
• •No major surgical procedure within 28 days prior to being registered for protocol therapy or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device and breast biopsy will not be considered major surgery.
• •No minor surgical procedure within 7 days prior to being registered for protocol therapy.
• •No known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage.
• •No known history of ischemic bowel.
• •No known history of deep venous thrombosis or pulmonary embolism.
• •No history of hypertensive crisis or hypertensive encephalopathy.
• •No non-healing wound or fracture.
• •No active infection requiring parenteral antibiotics.
• •No other hemorrhage/bleeding event ≥ CTCAE grade 3 within 28 days prior to being registered for protocol therapy.