Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
CT-P6
Herceptin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Herceptin, metastatic breast cancer, CT-P6
Eligibility Criteria
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
Sites / Locations
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CT-P6 & Paclitaxel
Herceptin & Paclitaxel
Arm Description
CT-P6 + Paclitaxel
Trastuzumab + Paclitaxel
Outcomes
Primary Outcome Measures
To Compare Efficacy
Secondary Outcome Measures
efficacy and safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01084876
Brief Title
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Acronym
Compare
Official Title
Double-blind, Randomised, Parallel Group, Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to to demonstrate equivalence
Detailed Description
Patients will receive study drug every 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Herceptin, metastatic breast cancer, CT-P6
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P6 & Paclitaxel
Arm Type
Active Comparator
Arm Description
CT-P6 + Paclitaxel
Arm Title
Herceptin & Paclitaxel
Arm Type
Active Comparator
Arm Description
Trastuzumab + Paclitaxel
Intervention Type
Drug
Intervention Name(s)
CT-P6
Intervention Description
Administered every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention Description
Administered every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered every 3weeks
Primary Outcome Measure Information:
Title
To Compare Efficacy
Time Frame
months
Secondary Outcome Measure Information:
Title
efficacy and safety
Time Frame
months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Investigational Site
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Baia-mare
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
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