HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18 lat i starsze z rakiem piersi, który rozprzestrzenił się na inne części ciała lub jest zaawansowany miejscowo.
- •Rak piersi, który nie zareagował na co najmniej jedną linię leczenia.
- •Pacjentka wyraża zgodę na udział w badaniu.
- •Istnieje co najmniej jedna zmiana przerzutowa o wielkości co najmniej 10 mm, która nadaje się do biopsji.
- •Istnieje co najmniej jedna dodatkowa zmiana przerzutowa (indeksowa) o wielkości co najmniej 10 mm, do oceny reakcji na leczenie.
- •Ogólny stan zdrowia pacjentki pozwala na udział w badaniu (stan sprawności WHO ≤ 2).
- •Oczekiwany czas przeżycia pacjentki wynosi ponad 12 tygodni.
✗ Disqualifies
- •Przeciwwskazania do przyjmowania leku T-DXd.
- •Pacjentka jest w ciąży, karmi piersią lub nie stosuje odpowiednich metod antykoncepcji (jeśli jest w wieku rozrodczym).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- November 20, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Karolinska University hospital
Solna, Sweden
Trial contact
Thuy Tran, Associate Prof, PharmD, PhD
Renske Altena, Associate Professor, MD PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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