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OncoMatch/Clinical Trials/NCT05376878

An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis

Is NCT05376878 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Trastuzumab and Trastuzumab Deruxtecan for anatomic stage iv breast cancer ajcc v8.

Phase 4RecruitingCity of Hope Medical CenterNCT05376878Data as of May 2026

Treatment: Positron Emission Tomography · Trastuzumab · Trastuzumab DeruxtecanThis clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Tumor Agnostic

Biomarker criteria

Required: HER2 (ERBB2) overexpression (HER2 positive (per ASCO/CAP guidelines))

HER2 positive breast cancer (American Society of Clinical Oncology [ASCO] College of American Pathologist [CAP] guidelines)

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

ANC > 1.5 x 10^9/L; Platelets > 100 x 10^9/L; Hemoglobin > 9 g/dL

Kidney function

Creatinine clearance > 30 ml/min (by Cockcroft-Gault formula)

Liver function

Total bilirubin < 3 x ULN; AST and ALT < 5 x ULN

Cardiac function

Left ventricular ejection fraction (LVEF) > 50%

Left ventricular ejection fraction (LVEF) > 50%; ANC > 1.5 x 10^9/L; Platelets > 100 x 10^9/L; Hemoglobin > 9 g/dL; Total (T.) bilirubin < 3 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x ULN; Creatinine clearance > 30 ml/min (by Cockcroft-Gault formula); Activated partial thromboplastin time (aPTT) < 1.5 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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