drugset / Trial / NCT06144944
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
Phase 3
Active not recruiting
160 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer
Timeline
- Start
- 2024-01-17
- Primary completion
- 2026-06-30
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |