CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 475 enrolled
Drug / intervention
CT-P6 +2 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/NCT01084876
NCT01084876Phase 3Completed

A Double-blind, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer

Celltrion·interventional·Posted Mar 11, 2010·Updated Feb 11, 2025

In Brief

A Phase 3 clinical trial evaluating CT-P6, Herceptin, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 475 participants across 1 site.

Detailed Summary

The purpose of the study is to demonstrate equivalence

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2010
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2012
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.3 years ago

Interventions

CT-P6drug

Administered every 3 weeks

Herceptindrug

Administered every 3 weeks

Paclitaxeldrug

Administered every 3 weeks