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

Inclusion Criteria:

Male and female patients 18 years of age or older
Karnofsky Performance Status (KPS) of 70 or higher
Capable of giving informed consent or have an acceptable surrogate capable of giving consent of the subject's behalf
Have a documented history of HER2/neu positive breast cancer that is 3+ on immunohistochemical staining or positive on fluorescent in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) and have evidence of parenchymal metastatic tumor(s) on brain imaging studies.
Adequate labs for procedure with trastuzumab, including but not limited to White Blood Count (WBC), Hemoglobin, Hematocrit, Platelet Count, Prothrombin Time (PT), International Normalized Ratio (INR), Sodium, Potassium, Chloride, Glucose, Blood Urea Nitrogen (BUN), Serum Creatinine (CR)

Exclusion Criteria:

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