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Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01084876
First received: March 9, 2010
Last updated: August 8, 2013
Last verified: August 2013

March 9, 2010
August 8, 2013
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 ClinicalTrials.gov 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.

Interventional
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
    Other Name: CT-P6
  • Drug: Herceptin
    Administered every 3 weeks
    Other Name: Trastuzumab
  • Drug: Paclitaxel
    Administered every 3weeks
    Other Name: Paclitaxel
  • Active Comparator: CT-P6 & Paclitaxel
    CT-P6 + Paclitaxel
    Interventions:
    • Drug: CT-P6
    • Drug: Paclitaxel
  • Active Comparator: Herceptin & Paclitaxel
    Trastuzumab + Paclitaxel
    Interventions:
    • Drug: Herceptin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
383
December 2013
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01084876
CT-P6/3.1
Yes
Celltrion
Celltrion
Not Provided
Principal Investigator: Investigational Site Samsung Medical Center
Celltrion
August 2013

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