Actively Recruiting
Pilot Study Evaluating 64Cu-DOTA-Trastuzumab PET/MRI Imaging in Patients With HER2-Positive Breast Cancer and Brain Metastases Treated With Fam-Trastuzumab Deruxtecan
Led by City of Hope Medical Center ยท Updated on 2026-02-23
10
Participants Needed
1
Research Sites
N/A
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
Researchers are studying an investigational imaging scan called 64Cu-DOTA-trastuzumab PET/MRI in patients with HER2-positive breast cancer that has spread to the brain. The study aims to see if this imaging method can detect cancer in the brain and show if the cancer absorbs trastuzumab, which might predict response to the standard chemotherapy drug trastuzumab deruxtecan. This research is a phase 4 clinical trial sponsored by City of Hope Medical Center. Participants receive an intravenous dose of trastuzumab on day 0, followed by an injection of 64Cu-DOTA-trastuzumab and a PET/MRI scan on day 1. After that, brain MRIs are repeated every 6 weeks for the first 24 weeks, then every 9 weeks until the disease progresses. If there is no disease progression or unacceptable side effects, patients receive intravenous trastuzumab deruxtecan every 21 days. During the study, participants undergo regular brain MRI scans and PET/MRI imaging to monitor cancer lesions. Researchers measure how much of the investigational tracer is taken up by brain tumors and compare uptake levels between patients who respond to treatment and those who do not. They also track progression-free survival and monitor for any disease progression or side effects. Participation may last up to five years or until disease progression or death.
CONDITIONS
Brief 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...
- Provided informed consent
- Women with metastatic HER2-positive breast cancer and brain metastases
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients with leptomeningeal disease eligible
- Planned treatment with fam-trastuzumab deruxtecan
- Left ventricular ejection fraction (LVEF) greater than 50%
- Absolute neutrophil count (ANC) 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
- Activated partial thromboplastin time (aPTT) less than 1.5 times the upper limit of normal
- Prior therapy for central nervous system disease allowed with at least one lesion greater than 1.5 cm visible on MRI
You will not qualify if you...
- Need for immediate local intervention for brain metastases
- Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
- Clinically significant corneal disease
- Recent myocardial infarction within 6 months, congestive heart failure, unstable angina, or serious cardiac arrhythmia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants receive trastuzumab intravenously on day 0, followed by 64Cu-DOTA-trastuzumab IV and a PET/MRI scan on day 1 to evaluate brain metastases.
2 visits (in-person)
Duration - Up to 5 years or until disease progression
Participants undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression to monitor brain metastases.
MRI visits every 6 weeks for 24 weeks, then every 9 weeks
Duration - Until disease progression or unacceptable toxicity
Participants receive trastuzumab deruxtecan intravenously every 21 days in the absence of disease progression or unacceptable toxicity.
IV infusion every 21 days
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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