Actively Recruiting
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
Led by City of Hope Medical Center · Updated on 2026-02-23
10
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This 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).
CONDITIONS
Official Title
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or legally authorized representative
- Women with metastatic HER2-positive breast cancer and brain metastases
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with leptomeningeal disease are eligible
- Planned treatment with fam-trastuzumab deruxtecan
- Left ventricular ejection fraction greater than 50%
- Absolute neutrophil count over 1.5 x 10^9/L
- Platelet count over 100 x 10^9/L
- Hemoglobin level above 9 g/dL
- Total bilirubin less than 3 times the upper limit of normal
- AST and ALT less than 5 times the upper limit of normal
- Creatinine clearance above 30 ml/min (Cockcroft-Gault formula)
- Activated partial thromboplastin time less than 1.5 times the upper limit of normal
- Prior therapy for CNS disease allowed if at least one brain lesion larger than 1.5 cm is visible on MRI
You will not qualify if you...
- Need for immediate local treatment for brain metastases
- Noninfectious interstitial lung disease or pneumonitis requiring steroid treatment
- Significant corneal disease
- Recent myocardial infarction within 6 months, congestive heart failure, unstable angina, or serious heart rhythm problems
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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