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Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer

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Trial Profile

Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2023

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At a glance

  • Drugs Trastuzumab (Primary) ; Docetaxel
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

    • Most Recent Events

    • 15 Feb 2023 According to a Shanghai Henlius Biotech media release, company announced, acceptance of Biologics License Application from US FDA for proposed biosimilar trastuzumab HLX02, based on clinical data of this trial.
    • 01 Jun 2022 Status changed from active, no longer recruiting to completed.
    • 07 Apr 2021 Results evaluating the efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with metastatic breast cancer, published in the BioDrugs
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