drugset / Trial / NCT04254263

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NCT04254263

Phase 3 Recruiting 316 enrolled RenJi Hospital
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

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral