Clinical Trial Details
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NCT02571530 : Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

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)

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

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
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