Spots Global Cancer Trial Database for A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
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Trial Identification
Brief Title: A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Official Title: 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
Study ID: NCT02149524
Study Description
Brief Summary: 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Investigational Site, Praha, , Czechia
Contact Details
Name: Xavier Pivot
Affiliation: CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale
Role: PRINCIPAL_INVESTIGATOR
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