drugset / Trial / NCT06770296
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study
Phase 1
Recruiting
200 enrolled
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Jiangsu University · collabAffiliated Hospital of Nantong University · collabShuyang County Traditional Chinese Medicine Hospital · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China · collabThe First People's Hospital of Xuzhou · collabThe Second People's Hospital of Changshu · collab
RandomizedSequentialOpen-labelTreatment
Summary
Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.
Timeline
- Start
- 2024-11-01
- Primary completion
- 2026-11-01
- Completion
- 2028-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |