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

NCT05720026 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2023-02-09

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shao Zhimin, Professor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2025-08-29
Completion
2026-02-21

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720026 on ClinicalTrials.gov