Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

• Drug: SU011248
  
  SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
  Other Name: sunitinib malate, Sutent
• Drug: Paclitaxel
  
  Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.

Inclusion Criteria:

• Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
• Candidate for treatment with paclitaxel.

Exclusion Criteria:

• Prior chemotherapy in the advanced disease setting.
• HER2 positive disease unless previously treated with trastuzumab.