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Study identifier: NCT06830382 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC

Condition: Breast Cancer Stage IV · HER2-low Breast Cancer · Molecular Imaging  ·  Sponsor: Renske Altena

PhaseN/A
Planned participants70
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Thuy Tran, Associate Prof, PharmD, PhD  ·  +46812377777  ·  thuy.tran@regionstockholm.se

Renske Altena, Associate Professor, MD PhD  ·  renske.altena@ki.se

Always discuss trial participation with your own doctor first.

Locations (1)

Karolinska University hospitalSolna, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT06830382