NCT02149524

A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

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: Phase 3
• Study type: Interventional
• Enrollment: 875 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• HER2 Positive Early or Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Herceptin (trastuzuamb)	Intravenous administration
DRUG	SB3 (proposed trastuzumab biosimilar)	Intravenous administration

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-03-01
• Completion: 2017-02-01
• First posted: 2014-05-29
• Last updated: 2018-10-24
• Results posted: 2018-10-24

Locations

1 site across 1 country: Czechia