Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Celltrion Identifier:
First received: March 9, 2010
Last updated: February 11, 2015
Last verified: February 2015

March 9, 2010
February 11, 2015
June 2010
December 2011   (final data collection date for primary outcome measure)
To Compare Efficacy [ Time Frame: months ] [ Designated as safety issue: No ]
ORR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
efficacy data, safety and PK [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Active, not recruiting
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
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