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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03321045 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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