A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Sorafenib; Bevacizumab; Imaging
Intervention description: Sorafenib 200mg po daily; Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks; Imaging every third cycle
Intervention MeSH terms: Bevacizumab; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent
      activity in previously treated advanced breast cancer. This trial will test combined VEGF
      inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced
      breast cancer.
    

Eligibility criteria:

        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.