Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
City of Hope Medical Center
With
National Cancer Institute (NCI)
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) 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
