OncoMatch/Clinical Trials/NCT06369831
HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011
Is NCT06369831 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for metastatic breast cancer.
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Allowed: HER2 (ERBB2) overexpression
HER2 IHC non-0 status assessed during the course of the study
Disease stage
Required: Stage IV
Excluded: Stage PRIMARY (NON-METASTATIC)
Metastatic disease required
Patient with confirmed de novo or pre-treated mBC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count <1,500 cells/mm3
Kidney function
GFR <30 ml/min/1.73m2
Liver function
Total bilirubin ~1.5 x ULN (unless Gilbert's syndrome); AST/SGOT or ALT/SGPT >5.0 x ULN
Inadequate organ function, suggested by clinically relevant abnormal laboratory results: Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2. Absolute neutrophil count <1,500 cells/mm3. Total bilirubin ~1.5 x ULN (unless the patient has documented Gilbert's syndrome). AST/SGOT or ALT/SGPT >5.0 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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