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A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin in Patients With HER2+ Early Breast Cancer

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A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin in Patients With HER2+ Early Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Sep 2024

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At a glance

  • Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin
  • Indications Advanced breast cancer; Carcinoma; Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROIKA
  • Sponsors Prestige BioPharma

    • Most Recent Events

    • 01 Aug 2024 According to a Prestige BioPharma media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue, a Herceptin (trastuzumab) biosimilar.
    • 31 Jan 2023 Final results (n=502) comparing efficacy (survival outcomes) and safety of HD201 versus referent trastuzumab in patients with ERBB2-positive breast cancer treated as neoadjuvant therapy, published in the BMC Cancer.
    • 21 Apr 2022 Status changed from active, no longer recruiting to completed.

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