drugset
drugset / Trial / NCT04398914

Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

NCT04398914 ↗

Phase 2 Active not recruiting 216 enrolled Shanghai Jiao Tong University School of Medicine Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

Timeline

Start
2020-05-30
Primary completion
2022-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Epirubicin Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications

invasive breast carcinoma