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Investigational Scan for HER2+ Breast Cancer with Brain Metastasis

This study is looking at a special scan called 64Cu-DOTA-Trastuzumab PET/MRI for people with HER2-positive breast cancer that has spread to the brain (brain metastasis). The goal is to see if this scan can help find HER2+ breast cancer in the brain and show if the cancer there takes up trastuzumab. This information might help doctors predict how well a standard chemotherapy called trastuzumab deruxtecan will work. The study aims to enroll 10 participants and is currently unclear on its recruitment status. Success will be measured by how many patients show quantifiable uptake on the scan and by comparing scan results between those who respond to treatment and those who don't, over a period of up to 5 years.

Study design
This is an interventional study, meaning participants will receive specific treatments and procedures. It aims to enroll 10 participants.
What's involved
You would receive trastuzumab intravenously (IV), then 64Cu-DOTA-Trastuzumab IV, and undergo a PET/MRI scan. You would also have repeat brain MRIs every 6-9 weeks, and receive trastuzumab deruxtecan IV every 21 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until disease progression or death, for up to 5 years.

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NCT05376878

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

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
City of Hope Medical Center
~10 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Copper Cu 64-DOTA-TrastuzumabMagnetic Resonance ImagingPositron Emission TomographyTrastuzumabTrastuzumab Deruxtecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake
Measured over Until disease progression or death, up to 5 years.
+1 more outcome measured

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain

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Breast CarcinomaMetastatic Malignant Neoplasm in the BrainERBB2 Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Joanne E Mortimer · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Joanne E. Mortimer
[email protected]
626-256-4673 · ext. 81218
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \[ASCO\] College of American Pathologist \[CAP\] guidelines) who have brain metastases
Age \> 18 years
Eastern Cooperative Oncology Group (ECOG) 0-2
Patients with leptomeningeal disease will be considered eligible
Planned therapy with fam-trastuzumab deruxtecan
Left ventricular ejection fraction (LVEF) \> 50%
Absolute neutrophil count (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
Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \> 1.5 cm is evident on MRI

Exclusion

Need for immediate local intervention for brain metastases
Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
Clinically significant corneal disease
Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia

What this trial measures

  • Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptakeUntil disease progression or death, up to 5 years.

    Percentage of patient with quantifiable 64Cu-DOTA-trastuzumab PET imaging (maximum standardized uptake value\[SUVmax\]) uptake in brain lesions.

  • Comparison of average min SUVmax values in responders versus non-responders.Until disease progression or death, up to 5 years.

    Comparison evaluated using a non-parametric test. The lowest SUVmax (minimum SUVmax) across the lesions will be the primary metric used. Response assessment for CNS disease is determined by MRI of the brain using Response Assessment in Neuro-Oncology (RANO) criteria.