Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer

Exclusion Criteria

• •1. Age less than 18 years
• •2. KPS less than 70
• •3. Brain metastases without history of HER2/neu positive breast cancer
• •4. Leptomeningeal dissemination of brain metastases
• •5. Pregnancy or refusal to use contraception during a 3 month period before and 7 month period after Intra-arterial (IA) trastuzumab administration
• •6. Prior administration of intraarterial trastuzumab
• •7. Subjects with inadequate baseline Left Ventricular Ejection Fraction (LVEF)
• •8. Subjects with history of infusion reaction with trastuzumab
• •9. Subjects who have had blood brain barrier (BBB) disruption with mannitol within 48 hours
• •10. Subjects with evidence of midline shift or herniation
• •11. Subjects with resectable brain metastases or whose cerebral tumors are amenable to stereotactic radio-surgery
• •12. Subjects who have not progressed after therapy for brain metastases