CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 875 enrolled
Drug / intervention
Herceptin (trastuzuamb) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02149524
NCT02149524Phase 3Completed
CompareCT.gov

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

Samsung Bioepis Co., Ltd.·interventional·Posted May 29, 2014·Updated Oct 24, 2018

In Brief

A Phase 3 clinical trial evaluating Herceptin (trastuzuamb) and SB3 (proposed trastuzumab biosimilar) for HER2 Positive Early or Locally Advanced Breast Cancer. Completed, enrolled 875 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2 Positive Early or Locally Advanced Breast Cancer
CountriesCzechia
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartApr 1, 2014
Primary CompletionMar 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.1 years ago

Interventions

Herceptin (trastuzuamb)drug

Intravenous administration

SB3 (proposed trastuzumab biosimilar)drug

Intravenous administration