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A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2025

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At a glance

  • Drugs Cyclophosphamide (Primary) ; Docetaxel (Primary) ; Doxorubicin (Primary) ; Pertuzumab (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 10 Dec 2025 According to a Shanghai Henlius Biotech media release, data from this study presented at the ESMO Asia 2025
  • 10 Dec 2025 Results published in the Media Release
  • 26 Nov 2025 According to a Shanghai Henlius Biotech media release, company has announced that HLX11 was approved by the U.S. FDA as an interchangeable biosimilar to PERJETA (pertuzumab), making it the first approved pertuzumab biosimilar in the U.S. The marketing applications are under review in the EU, Canada and China.

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