OncoMatch/Clinical Trials/NCT03321045
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Is NCT03321045 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies [89Zr]-Df-Trastuzumab for breast cancer.
Treatment: [89Zr]-Df-Trastuzumab — Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
Immunohistochemistry (IHC) 3+
Required: HER2 (ERBB2) amplification (average HER2 copy number >= 6)
Single probe In situ hybridization (ISH) with average HER2 copy number >= 6
Required: HER2 (ERBB2) amplification (average HER2 copy number >= 4 AND HER2 to CEP17 ratio >=2)
dual probe ISH with both average HER2 copy number >= 4 AND HER2 to CEP17 ratio >=2
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Cardiac function
ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (muga) scans
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Kirklin Clinic · Birmingham, Alabama
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