drugset / Trial / NCT05841381

Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer

NCT05841381

Phase 3 Not yet recruiting 876 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer

Timeline

Start
2023-05-06
Primary completion
2028-05-06
Completion
2033-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral
Background Paclitaxel Small molecule 80 mg/m2
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications