A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

• Drug: Sunitinib + Capecitabine
  

  Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.

  Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.

• Drug: Capecitabine
  
  Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

• Experimental: A
  
  Intervention: Drug: Sunitinib + Capecitabine
• Active Comparator: B
  
  Intervention: Drug: Capecitabine

Inclusion Criteria:

• Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
• Previous treatment with an anthracycline and a taxane in any setting
• Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

• History of inflammatory carcinoma if there is no other measurable disease
• More than 2 chemotherapy agents in the advanced disease setting
• Brain metastases