64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer
I. Determine the dose of pre-administered cold antibody that optimizes image quality of
64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with
metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor
expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on
64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
This is a part one dose-determining study followed by a part two study. PART ONE: Patients
are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after
injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours
after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET
24 and 28 hours after injection of 64 CU-DOTA-trastuzumab
Beckman Research Institute
United States: Institutional Review Board
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