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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Celltrion

Tracking Information
First Submitted Date  ICMJE March 9, 2010
First Posted Date  ICMJE March 11, 2010
Last Update Posted Date February 12, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2010)
To Compare Efficacy [ Time Frame: months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2010)
efficacy and safety [ Time Frame: months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Official Title  ICMJE Double-blind, Randomised, Parallel Group, Phase III Study
Brief Summary The purpose of the study is to to demonstrate equivalence
Detailed Description Patients will receive study drug every 3 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: CT-P6
    Administered every 3 weeks
  • Drug: Herceptin
    Administered every 3 weeks
    Other Name: Trastuzumab
  • Drug: Paclitaxel
    Administered every 3weeks
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 20, 2011)
383
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
220
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01084876
Other Study ID Numbers  ICMJE CT-P6/3.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Investigational Site Samsung Medical Center
PRS Account Celltrion
Verification Date February 2015

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