OncoMatch/Clinical Trials/NCT06369831
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
Is NCT06369831 recruiting? Yes, currently enrolling (Sep 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
Required: FDG positive
FDG positive, non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment)
Disease stage
Required: Stage IV
Excluded: Stage PRIMARY (NON-METASTATIC)
Metastatic disease required
Patient with confirmed de novo or pre-treated metastatic solid tumors; Primary (non-metastatic) solid tumor cancer [excluded]
Prior therapy
Cannot have received: anticoagulation therapy
Exception: temporary discontinuation of this therapy cannot be safely performed
Patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed
Lab requirements
Blood counts
Absolute neutrophil count <1,500 cells/mm3
Kidney function
Significantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2
Liver function
Total bilirubin ~1.5 x ULN (unless the patient has documented 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 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.
Frequently asked questions
Is NCT06369831 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticoagulation therapy disqualifies patients from enrollment.
Does this trial require FDG?
Yes, FDG positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages