Condition: Breast Cancer Stage IV · HER2-low Breast Cancer · Molecular Imaging · Sponsor: Renske Altena
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy. The overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \[68Ga\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd. The study hypothesis is that PET/CT precision imaging with a contemporary HER2-radiotracer (\[68Ga\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.
This description comes directly from the study's public registry record.
Thuy Tran, Associate Prof, PharmD, PhD · +46812377777 · thuy.tran@regionstockholm.se
Renske Altena, Associate Professor, MD PhD · renske.altena@ki.se
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| Karolinska University hospital | Solna, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06830382