NCT01084876

Demonstrate Efficacy and Safety of Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Celltrion · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate equivalence

Detailed description

Patients will receive CT-P6 or Herceptin every 3 weeks.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	CT-P6	Administered every 3 weeks
DRUG	Herceptin	Administered every 3 weeks
DRUG	Paclitaxel	Administered every 3 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-07-01
• Completion: 2015-03-01
• First posted: 2010-03-11
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

1 site across 1 country: South Korea