CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 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/NCT01084863
NCT01084863Phase 2Completed

A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer

Celltrion·interventional·Posted Mar 11, 2010·Updated Jan 24, 2025

In Brief

A Phase 2 clinical trial evaluating CT-P6, Herceptin, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 143 participants across 1 site.

Detailed Summary

The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2010
Enrollment StartFeb 1, 2010
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

CT-P6drug

CT-P6: administered every 3 weeks

Herceptindrug

Herceptin: administered every 3 weeks

Paclitaxeldrug

Paclitaxel: administered every 3 weeks