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Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

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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

Brief Summary:
The purpose of the study is to to demonstrate equivalence

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: CT-P6 Drug: Herceptin Drug: Paclitaxel Phase 3

Detailed Description:
Patients will receive study drug every 3 weeks.

Study Type : Interventional  (Clinical Trial)
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 : June 2010
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Trastuzumab
Drug: Paclitaxel
Administered every 3weeks



Primary Outcome Measures :
  1. To Compare Efficacy [ Time Frame: months ]

Secondary Outcome Measures :
  1. efficacy and safety [ Time Frame: months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084876


Locations
Romania
Investigational Site
Baia-mare, Romania
Sponsors and Collaborators
Celltrion
Investigators
Principal Investigator: Investigational Site Samsung Medical Center

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01084876     History of Changes
Other Study ID Numbers: CT-P6/3.1
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Celltrion:
Herceptin
metastatic breast cancer
CT-P6

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action