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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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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: 01 Apr 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

  • 28 Mar 2025 According to a Shanghai Henlius Biotech media release, company announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab). The submission was based on this phase 3 trial.
  • 02 Feb 2025 According to a Shanghai Henlius Biotech media release, the Biologic license application for HLX11 has been accepted by the USFDA. This BLA filing is based on data from a series of studies for HLX11 versus Perjeta, including this study, along with other analytical similarity studies and comparative clinical studies. Previously, the new drug application (NDA) for HLX11 was accepted by National Medical Products Administration (NMPA).
  • 30 Sep 2024 Results published in the Shanghai Henlius Biotech Media Release

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