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A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer

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A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs Trastuzumab (Primary) ; Anthracyclines; Cyclophosphamide; Epirubicin; Paclitaxel
  • Indications Carcinoma; Early breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors EirGenix

    • Most Recent Events

    • 22 Nov 2023 According to an EirGenix media release, the trastuzumab biosimilar medicine (EG12014) has received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin.
    • 18 Sep 2023 According to Novartis media release, Sandoz has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use), developed by EirGenix, Inc.
    • 18 Nov 2022 Status changed from active, no longer recruiting to completed as per results presented at the 13th European Breast Cancer Conference

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