Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2

This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.

Inclusion Criteria:

• Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
• Tumors over-expressing Her-2
• Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

• Histology of inflammatory carcinoma
• AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN