Clinical Trial

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Active, Not Recruiting Phase 3
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Summary
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs. EU-Perjeta® on HER2-positive and HR-negative early-stage or locally advanced breast cancer with a primary tumor \> 2 cm. Patients are random assignment to 2 arms and treatment with either HLX11 or EU-Perjeta® , and received neoadjuvant THP regimen every 3- weeks 4 cycles，adjuvant AC every 3- weeks 4 cycles and pertuzumab+trastuzumab(HP) every 3- weeks 13cycles.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-04-23; most recent amendment 2025-06-05.
Status change: Recruiting → Active, Not Recruiting 2024-04-14
Trial Details
NCT Number NCT05346224
Lead Sponsor Shanghai Henlius Biotech
Conditions Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
Enrollment 900 participants
Start Date 2022-04-25
Primary Completion 2024-05-15 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-10