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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2019

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At a glance

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

    • 26 Jan 2018 Primary endpoint of breast pathologic complete response (bpCR) rate has been met, according to results published in the Journal of Clinical Oncology.
    • 26 Jan 2018 Results published in the Journal of Clinical Oncology
    • 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.
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