drugset / Trial / NCT05704829
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
RandomizedCrossoverOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2024-02-05
- Primary completion
- 2030-06
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Pertuzumab | Monoclonal antibody | — | — |
| Subject | Trastuzumab | Monoclonal antibody | — | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |