This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography [PET]/magnetic resonance imaging [MRI]) in imaging patients with HER 2 low and HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2 low and 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).
Additional locations may be listed on ClinicalTrials.gov for NCT05376878.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer CenterStatus: Active
Contact: Joanne E. Mortimer
Phone: 626-256-4673ext81218
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of 64Cu-DOTA-trastuzumab PET imaging in patients with HER2 low and HER2+ breast cancer metastatic to the brain.
II. Evaluate if HER2 low and 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 then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until discontinuation of trastuzumab deruxtecan. Patients also undergo echocardiography (ECHO) during screening.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorJoanne E. Mortimer
