An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
NCT ID: NCT05376878
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
10 participants
INTERVENTIONAL
2022-12-21
2026-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
64-Cu Labeled Brain PET/MRI for MM-302 in Advanced HER2+ Cancers With Brain Mets
NCT02735798
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
NCT02226276
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
NCT06072807
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
NCT06797622
64Cu-DOTA Pembrolizumab for Imaging Metastatic Solid Tumors in Patients Receiving Stereotactic Body Radiation
NCT05728372
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Evaluate the feasibility of 64Cu-DOTA-trastuzumab PET imaging in patients with HER2+ breast cancer metastatic to the brain.
II. Evaluate if HER2+ breast cancer patients with brain metastasis who are responders to fam-trastuzumab deruxtecan have higher maximum standardized uptake value (SUVmax) (minimum over all lesions in the brain) than non-responders.
SECONDARY OBJECTIVE:
I. Evaluate if the minimum SUVmax of all quantifiable lesions in a given patient is associated with time to progression in the brain.
OUTLINE:
Patients receive trastuzumab intravenously (IV) over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET/MRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)
Patients receive trastuzumab IV over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET/MRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.
Copper Cu 64-DOTA-Trastuzumab
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Trastuzumab
Given IV
Trastuzumab Deruxtecan
Given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Copper Cu 64-DOTA-Trastuzumab
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Trastuzumab
Given IV
Trastuzumab Deruxtecan
Given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joanne E Mortimer
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Medical Center
Duarte, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2022-03220
Identifier Type: REGISTRY
Identifier Source: secondary_id
21050
Identifier Type: OTHER
Identifier Source: secondary_id
21050
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.