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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
Conditions
Interventions
Herceptin (trastuzuamb)
SB3 (proposed trastuzumab biosimilar)
Locations
1
Czechia
Investigational Site
Prague, Czechia
Start Date
April 1, 2014
Primary Completion Date
March 1, 2016
Completion Date
February 1, 2017
Last Updated
October 24, 2018
Lead Sponsor
Samsung Bioepis Co., Ltd.
Data Source & Attribution
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