drugset / Trial / NCT03756064

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

NCT03756064

Unknown 100 enrolled Zhejiang Cancer Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Timeline

Start
2019-08-01
Primary completion
2020-07-31
Completion
2021-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral
Background Carboplatin Small molecule 5 unknown
Background Docetaxel Small molecule 75 mg/m2
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications