- 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.
- 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.