Condition: Breast Cancer · Sponsor: Prof. Wolfgang Janni
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)
This description comes directly from the study's public registry record.
Wolfgang Janni, Prof. Dr. med. · +49731 500 58536 · studienzentrale.ufk@uniklinik-ulm.de
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| University Clinic Ulm | Ulm, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06643585