NCT05720026View on ClinicalTrials.gov

Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

January 9, 2023

Primary Completion Date

August 29, 2025

Study Completion Date

February 21, 2026

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

SYSA1901

loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle

DRUG

Pertuzumab

loading dose of 840 mg IV, followed by 420 mg IV, q3w/cycle, total 4cycle

DRUG

Trastuzumab

loading dose of 8 mg/kg IV, followed by 6 mg/kg IV, q3w/cycle, total 4cycle

DRUG

Docetaxel

75 mg/m\^2 IV, q3w/cycle, total 4cycle

Trial Locations (1)

Unknown

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY