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NCT05704829 · ClinicalTrials.gov record · last posted 2026-06-09

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

Study acronym: ADAPTHER2-IV
StatusRecruiting
PhasePhase 2
Started2024-02-05
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from the ClinicalTrials.gov record
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).

Protocol amendment history 1 change detected by DataLookout

2026-08-09
Sponsor changed: West German Study Group → Women's Cancer Study Group GmbH
WasWest German Study Group
NowWomen's Cancer Study Group GmbH
Trial Details
NCT Number NCT05704829
Lead Sponsor West German Study Group
Collaborators: AstraZeneca
Conditions HER2-positive Early Breast Cancer
Enrollment 702 participants
Start Date 2024-02-05
Primary Completion 2030-06 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-09