drugset / Trial / NCT03980054

A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

NCT03980054

Phase 3 Unknown 1192 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Timeline

Start
2019-07-12
Primary completion
2022-07-31
Completion
2024-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral

Indications