This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments ct-p6, herceptin, paclitaxel
Phase phase 3
Target HER2
Sponsor Celltrion
Start date June 2010
End date December 2011
Trial size 383 participants
Trial identifier NCT01084876, CT-P6/3.1


The purpose of the study is to to demonstrate equivalence

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
CT-P6 + Paclitaxel
ct-p6 CT-P6
Administered every 3 weeks
paclitaxel Paclitaxel
Administered every 3weeks
(Active Comparator)
Trastuzumab + Paclitaxel
herceptin Trastuzumab
Administered every 3 weeks
paclitaxel Paclitaxel
Administered every 3weeks

Primary Outcomes

To Compare Efficacy
time frame: months

Secondary Outcomes

efficacy and safety
time frame: months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Are females - Have a Her 2 over-expression - Have ECOG 0 or 1 Exclusion Criteria: - Current clinical or radiographic evidence CNS metastases - Current Known infection - Pregnant or nursing mother

Additional Information

Official title Double-blind, Randomised, Parallel Group, Phase III Study
Principal investigator Investigational Site
Description Patients will receive study drug every 3 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Celltrion.