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Compare: Demonstrate Efficacy and Safety of Metastatic Breast Cancer

Sponsor
Celltrion (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01084876
Collaborator
(none)
383
Enrollment
1
Location
2
Arms
90
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to to demonstrate equivalence

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Patients will receive study drug every 3 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
383 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Double-blind, Randomised, Parallel Group, Phase III Study
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CT-P6 & Paclitaxel

CT-P6 + Paclitaxel

Drug: CT-P6
Administered every 3 weeks

Drug: Paclitaxel
Administered every 3weeks
Active Comparator: Herceptin & Paclitaxel

Trastuzumab + Paclitaxel

Drug: Herceptin
Administered every 3 weeks
Other Names:
  • Trastuzumab

    • Drug: Paclitaxel
    Administered every 3weeks

    Outcome Measures

    Primary Outcome Measures

    1. To Compare Efficacy [months]

    Secondary Outcome Measures

    1. efficacy and safety [months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Baia-mare Romania

    Sponsors and Collaborators

    • Celltrion

    Investigators

    • Principal Investigator: Investigational Site, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celltrion
    ClinicalTrials.gov Identifier:
    NCT01084876
    Other Study ID Numbers:
    • CT-P6/3.1
    First Posted:
    Mar 11, 2010
    Last Update Posted:
    Feb 12, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Celltrion
    Herceptin
    metastatic breast cancer
    CT-P6
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel
    Trastuzumab

    Study Results

    No Results Posted as of Feb 12, 2015