Evaluation of 64Cu-DOTA-Trastuzumab PETMRI Scan for Adults with HER2 Positive Breast Cancer and Brain Metastases Using Trastuzumab Deruxtecan Chemotherapy

What this Trial Is About

Researchers are evaluating an investigational imaging scan called 64Cu-DOTA-trastuzumab PETMRI in adults with HER2 positive breast cancer that has spread to the brain. The study aims to assess if this imaging can identify brain metastases and predict which patients might respond to trastuzumab deruxtecan, a standard chemotherapy. This is a phase 4 study focused on diagnostic imaging and treatment response prediction. Participants receive an intravenous dose of trastuzumab on day 0, followed by 64Cu-DOTA-trastuzumab and a PETMRI scan on day 1. They then have repeat brain MRIs every 6 weeks for 24 weeks, then every 9 weeks until their disease progresses. If the disease has not progressed or toxicity is acceptable, participants receive trastuzumab deruxtecan intravenously every 21 days. During the study, participants undergo brain imaging and laboratory tests to monitor disease status and treatment effects. Researchers measure the ability of the scan to detect brain lesions and compare uptake values between responders and non-responders. They also track progression-free survival and safety over up to 5 years. The study includes regular evaluations to monitor disease progression and treatment tolerance.

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