1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

Exclusion Criteria

• •Patients with active brain metastases.
• •Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
• •Prior use of gemcitabine/capecitabine or sorafenib.
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Serious, non-healing wound, ulcer, or bone fracture.
• •Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
• •Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.
• •Clinically significant cardiac disease
• •Uncontrolled hypertension
• •Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• •Pulmonary hemorrhage/bleeding event \> NCI-CTCAE Grade 2 within 4 weeks of randomization.
• •Any other hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks of randomization.
• •Active clinically serious infection \> NCI-CTCAE Grade 2.
• •Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).
• •Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors \[Ta and Tis\] or any cancer curatively treated \> 5 years prior to randomization.
• •Known or suspected allergy to sorafenib or gemcitabine/capecitabine.
• •Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.
• •Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.
• •Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.
• •Women who are pregnant or breast-feeding.
• •Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.
• •Inability to comply with protocol and/or not willing or not available for follow-up assessments.
• •Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.