Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
City of Hope Medical Center
Summary
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).
Description
PRIMARY OBJECTIVES: 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) ove…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 \>…
Interventions
- OtherCopper Cu 64-DOTA-Trastuzumab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo PET/MRI
- DevicePositron Emission Tomography
Undergo PET/MRI
- BiologicalTrastuzumab
Given IV
- BiologicalTrastuzumab Deruxtecan
Given IV
Location
- City of Hope Medical CenterDuarte, California