drugset / Trial / NCT04066790
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Phase 2
Terminated
12 enrolled
Shanghai Jiao Tong University School of Medicine
Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
Timeline
- Start
- 2019-09-09
- Primary completion
- 2020-04-30
- Completion
- 2020-04-30
Outcome
Outcome not reported
Stopped: “We terminated this trial and initiated a new one including pertuzumab.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |