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

Inclusion Criteria:

• Histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease. NOTE: Patients with Her-2 positive (3+ by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.
• Must have measurable or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
• Two or fewer prior chemotherapy regimens in any disease setting. NOTE: All adjuvant and neoadjuvant chemotherapy will be considered one regimen. NOTE: Prior hormonal therapy for metastatic disease is allowed. NOTE: Prior radiation therapy is allowed as long as the irradiated area is not the only source of evaluable disease.
• Age > 18 years at the time of consent.
• Written informed consent and HIPAA authorization for release of personal health information.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
• Ability to comply with study and/or follow-up procedures.

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.