The study will evaluate \[68Ga\]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.
Open-labeled, exploratory, single center study. 1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. \[68Ga\]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third \[68Ga\]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable. 2. Group 2 Ten subjects with HER2-positive primary tumor status. \[68Ga\]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second \[68Ga\]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Intravenous injection followed by PET imaging
Uppsala University Hospital
Uppsala, Sweden
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
Time frame: Day 0
SUV in metastases where biopsy results with HER2 status by IHC/FISH are available
Time frame: Day 0
SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy
Time frame: Up to 1 year
SUV for each measured lesion and number of detectable lesions, obtained with a low (100 μg) or high (500 μg) injected amount of ABY-025 peptide in the same subject
Time frame: Day 0 & 1-3 weeks
SUVs for all measured lesions obtained with a low (100 μg) or high (500 μg) injected where biopsy results with HER2 status by IHC and FISH are available
Time frame: Day 0
Incidence and severity of adverse events
Time frame: Day 0 to 42
Anti-Drug Antibody assay at 3 and 6 weeks
Time frame: Day 0 to 42
Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025
Time frame: Day 0
Uptake of [68Ga]ABY-025 coinciding with metastatic lesions visible on [18F]FDG PET and focal uptake in regions without pathological findings on [18F]FDG PET
Time frame: Day 0
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