NCT04290793

Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

Pyrotinib Combined With Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab in Neoadjuvant Therapy of HER2-positive Early Breast Cancer: a Single-arm, Open-label, Multicenter Phase II Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	400mg administered as continuous oral once daily from the first day of the study
DRUG	Epirubicin	90mg/m\^2 d1 iv Q2W for 4 cycles
DRUG	Cyclophosphamide	600 mg/m\^2 d1 iv Q2W for 4 cycles
DRUG	Taxanes	Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
BIOLOGICAL	Trastuzumab	the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W

Timeline

• Start date: 2020-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-10
• First posted: 2020-03-02
• Last updated: 2026-01-07

Locations

1 site across 1 country: China