Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
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
The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Pisemna zgoda na udział w badaniu
- •Potwierdzony nowotwór piersi z guzem ≥20 mm i/lub przerzutami do okolicznych węzłów chłonnych
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Znany status receptorów estrogenowych i/lub progesteronowych (dodatni jeśli ≥10% komórek)
- •Potwierdzony dodatni status HER2 (3+ lub 2+ z dodatnim testem FISH)
- •Prawidłowa funkcja serca, wątroby i nerek potwierdzona badaniami krwi
- •Dla kobiet: ujemny test ciążowy lub stosowanie skutecznej antykoncepcji
✗ Disqualifies
- •Uczestnictwo w innych badaniach klinicznych
- •Przerzuty do odległych organów lub węzłów chłonnych poza okolicznym obszarem
- •Inne nowotwory zdiagnozowane w ostatnich 5 latach (z wyjątkami dla raka skóry)
- •Historia poprzedniego inwazyjnego raka piersi
- •Historia DCIS (oprócz pacjentów po mastektomii przed >5 laty)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 2, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
Skåne University Hospital
Malmö, Sweden
Örebro University Hospital
Örebro, Sweden
Sankt Gorans Hospital
Stockholm, Sweden
Stockholm Southern Hospital
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Norrlands University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Trial contact
Mats Hellström, BSc
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.