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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

StatusActive, Not Recruiting
PhasePhase 3
Started2022-04-25
View on ClinicalTrials.gov ↗

Amendment history

2025-06-05
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing, References v5
Study sites16→79
Publicationsdetails revised at 1 of 1 entry
Study titlerevised
A Study to Evaluate the Efficacy and Safety of HLX11 Vsvs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
2025-02-22
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing, References v4
Primary completion dateestimated 2024-11-30→confirmed 2024-05-15
Study sites1→16
Publicationsdetails revised at 1 of 1 entry
Study titlerevised
A Study to Evaluate the Efficacy and Safety of HLX11 vsVs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
2024-04-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2023-08-07
Study Status, Contacts/Locations, References v2
2022-04-28
Study Status, Conditions, Arms and Interventions, Contacts/Locations v1
Primary completion date2023-12-30→2024-11-30
Start date2022-03-01→2022-04-25
InterventionsEU-Perjeta® (Biological), HLX11 (Biological)→EU-Perjeta® (Drug), HLX11 (Drug)
Study sites1 entry, revised
ShanghaiSun HenliusYat-Sun Biotech,Yat-sen IncHospital affiliated to Sun Yat-sen Universitysen Hospital affiliated to Sun Yat-sen University
2022-04-23
Original filing
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.
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