Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 17, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2031

Conditions
Breast Cancer InvasiveHormone-receptor-positive Breast CancerHER2 Low Breast CarcinomaEarly-stage Breast Cancer
Interventions
DRUG

Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Pyrotinib 320 mg orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

DRUG

Epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Trial Locations (1)

510120

RECRUITING

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER