NCT01084863

Evaluate Safety, Efficacy and Pharmacokinetics

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Celltrion · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients will receive CT-P6 or Herceptin.

Conditions

• Metastatic Breast Cancer

Interventions

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

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-12-01
• Completion: 2023-12-01
• First posted: 2010-03-11
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: South Korea