A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

• Drug: Sunitinib
  
  Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
  Other Name: SU011248, Sutent
• Drug: paclitaxel
  
  Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
• Drug: bevacizumab
  
  Bevacizumab 10 mg/kg IV every 2 weeks.
  Other Name: Avastin

• Experimental: A
  
  Interventions:
  

  • Drug: Sunitinib
  • Drug: paclitaxel
• Active Comparator: B
  
  Interventions:
  

  • Drug: bevacizumab
  • Drug: paclitaxel

Inclusion Criteria:

• Diagnosis of advanced breast cancer.
• Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

• No prior treatment with cytotoxics in the advanced disease setting.
• HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
• Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.