drugset / Trial / NCT06162559
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.
Timeline
- Start
- 2023-12-18
- Primary completion
- 2026-08
- Completion
- 2036-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | 600 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |