drugset / Trial / NCT04254263
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Timeline
- Start
- 2019-12-16
- Primary completion
- 2026-08
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |