A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

Trial Profile

A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Advanced breast cancer; Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 12 Sep 2017 One-year results on safety, immunogenicity, event-free-survival (EFS), and overall survival (OS) presented at the 42nd European Society for Medical Oncology Congress.
    • 06 Jun 2017 Results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 12 Apr 2017 Status changed from active, no longer recruiting to completed.
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