Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwell Health
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and female patients 18 years of age or older
2. Karnofsky Performance Status (KPS) of 70 or higher
3. Capable of giving informed consent or have an acceptable surrogate capable of giving consent of the subject's behalf
4. 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.
5. 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)
You may not be if
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
Clareo Health | Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
