drugset / Trial / NCT06254690
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
Phase 2
Recruiting
102 enrolled
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Jiangnan University · collabAffiliated Hospital of Jiangsu University · collabAffiliated Hospital of Nantong University · collabAnhui Provincial Cancer Hospital · collabHuai'an First People's Hospital · collabJingjiang People's Hospital · collabSuzhou Municipal Hospital · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabYancheng First People's Hospital · collabZhongda Hospital · collab
RandomizedSequentialOpen-labelTreatment
Summary
Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer
Timeline
- Start
- 2024-01-01
- Primary completion
- 2026-11-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |