Clinical trial NCT00632541 (phase 2, status: terminated)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: sorafenib, bevacizumab
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    significant toxicities experienced
  
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.