NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

Trial Details

NCT ID
NCT05704829
Phase
PHASE2
Sponsor
Women's Cancer Study Group GmbH
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab deruxtecan
  • Standard-of-Care
Locations (sample)
  • Baden-Baden, Baden-Wurttemberg, Germany|48.7606,8.23975
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany|47.9959,7.85222
  • Tübingen, Baden-Wurttemberg, Germany|48.52266,9.05222
  • Ulm, Baden-Wurttemberg, Germany|48.39841,9.99155
  • Augsburg, Bavaria, Germany|48.37154,10.89851

Key Eligibility Criteria

  • Patients eligible for inclusion in this study must meet all the following criteria:
  • 1\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-…
  • absolute neutrophil count ≥ 1.5 × 109/L,
  • platelets ≥ 100 × 109/L,

For full eligibility, visit ClinicalTrials.gov.

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