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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

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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: 09 Feb 2023

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Early breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

Most Recent Events

  • 02 Feb 2022 According to a Samsung Bioepis media release, the Health Canada has approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and metastatic gastric cancer (MGC), based on a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data.
  • 12 Sep 2021 According to a Samsung Bioepis media release, the company look forward to share data with the oncology community on the usage of biosimilars based on this long-term follow-up data.
  • 12 Sep 2021 According to a Samsung Bioepis media release, data from this study will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2021.

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