A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse
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
Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to: * Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier * Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 75 lat
- •Diagnoza raka piersi potwierdzzona badaniem patologicznym (HER2-dodatni lub HER2-niski)
- •Całkowite usunięcie guza bez pozostałości choroby
- •Uczestnictwo w badaniu SURVIVE ze stwierdzonym nawrotem molekularnym (pozytywny wynik testu ctDNA)
- •Brak przerzutów potwierdzony badaniami obrazowymi (TK, scyntygrafia kości)
- •Zakończenie operacji, chemioterapii i radioterapii co najmniej 6 miesięcy przed włączeniem
- •Funkcja lewej komory serca (LVEF) ≥50%
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-1)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- May 2, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
University Clinic Ulm
Ulm, Germany
Trial contact
Wolfgang Janni, Prof. Dr. med.
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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