Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Inclusion Criteria:

• A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
• HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
• Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

• Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
• Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
• Prior treatment on a SU11248 clinical trial.
• Uncontrolled brain metastases.