NCT05720026

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

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase Ⅲ Clinical Study to Compare the Efficacy and Safety of SYSA1901 vs Pertuzumab (Perjeta®) in the Neoadjuvant Therapy of HER2-Positive Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor \> 2 cm.

Detailed description

This is a phase Ⅲ, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of SYSA1901 + trastuzumab + docetaxel vs. Perjeta® + trastuzumab + docetaxel in the patients with early-stage or locally advanced HER2-positive and HR-negative breast cancer with a primary tumor \> 2 cm. The eligible patients will be randomized to treatment group (SYSA1901 + Trastuzumab + Docetaxel) or control group (Perjeta® + Trastuzumab + Docetaxel) at 1:1 ratio. The stratification factor is disease category (early-stage vs. locally advanced). The primary endpoint is total pCR (tpCR). Secondary efficacy endpoints include breast pCR (bpCR), objective response rate (ORR)，pharmacokinetic (PK) and immunogenicity.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-08-29
• Completion: 2026-02-21
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: China