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

NCT02149524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 875

Last updated 2018-10-24

Study results available
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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

DRUG

Herceptin (trastuzuamb)

Intravenous administration

DRUG

SB3 (proposed trastuzumab biosimilar)

Intravenous administration

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xavier Pivot · CHU Besançon Hopital Jean Minjoz Service d'Oncologie Medicale

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2017-02-28

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149524 on ClinicalTrials.gov