drugset / Trial / NCT06548178
T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer
RandomizedParallel-groupSingle-blindTreatment
Summary
This study (EXTEND trial) is a multicentre, interventional, prospective, randomised, open-label, controlled neoadjuvant, phase 2 trial evaluating the efficacy and safety of T-DXd monotherapy vs. standard-of-care docetaxel+ trastuzumab + pertuzumab (THP) in medium-risk (lymph node negative with a primary tumour stage T2) HER2-positive early breast cancer.
Timeline
- Start
- 2024-09
- Primary completion
- 2025-09
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | — |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | — |