A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse

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 treatm

Trial Details

NCT ID
NCT06643585
Phase
PHASE3
Sponsor
Prof. Wolfgang Janni
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab-Deruxtecan
  • Physicians Choice (PhC).
Locations (sample)
  • Ulm, Germany|48.39841,9.99155

Key Eligibility Criteria

  • Patients will be eligible for study participation if they comply with the following criteria:
  • Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
  • Females or males, ≥ 18 years and ≤ 75 years of age.
  • Invasive breast carcinoma as revealed by local pathology that is either:

For full eligibility, visit ClinicalTrials.gov.

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