Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084876
Recruitment Status : Unknown
Verified February 2015 by Celltrion.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2010
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):

March 9, 2010
March 11, 2010
February 12, 2015
June 2010
December 2011   (Final data collection date for primary outcome measure)
To Compare Efficacy [ Time Frame: months ]
ORR [ Time Frame: 6 months ]
to demonstrate equivalence of CT-P6 and Herceptin, both given in combination with paclitaxel, in terms of efficacy determined by overall response rate (ORR).
Complete list of historical versions of study NCT01084876 on Archive Site
efficacy and safety [ Time Frame: months ]
efficacy data, safety and PK [ Time Frame: 6 months ]
to obtain additional efficacy data, to demonstrate comparable safety, and to demonstrate pharmacokinetic (PK) bioequivalence in terms of trough concentration at steady state (CtroughSS), of CT-P6 in comparison to Herceptin in patients with metastatic breast cancer
Not Provided
Not Provided
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Double-blind, Randomised, Parallel Group, Phase III Study
The purpose of the study is to to demonstrate equivalence
Patients will receive study drug every 3 weeks.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: CT-P6
    Administered every 3 weeks
  • Drug: Herceptin
    Administered every 3 weeks
    Other Name: Trastuzumab
  • Drug: Paclitaxel
    Administered every 3weeks
  • Active Comparator: CT-P6 & Paclitaxel
    CT-P6 + Paclitaxel
    • Drug: CT-P6
    • Drug: Paclitaxel
  • Active Comparator: Herceptin & Paclitaxel
    Trastuzumab + Paclitaxel
    • Drug: Herceptin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2017
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Principal Investigator: Investigational Site Samsung Medical Center
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP