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
  Purpose

The purpose of the study is to to demonstrate equivalence


Condition Intervention Phase
Metastatic Breast Cancer
Drug: CT-P6
Drug: Herceptin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomised, Parallel Group, Phase III Study

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • To Compare Efficacy [ Time Frame: months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy and safety [ Time Frame: months ] [ Designated as safety issue: Yes ]

Enrollment: 383
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CT-P6 & Paclitaxel
CT-P6 + Paclitaxel
Drug: CT-P6
Administered every 3 weeks
Other Name: CT-P6
Drug: Paclitaxel
Administered every 3weeks
Other Name: Paclitaxel
Active Comparator: Herceptin & Paclitaxel
Trastuzumab + Paclitaxel
Drug: Herceptin
Administered every 3 weeks
Other Name: Trastuzumab
Drug: Paclitaxel
Administered every 3weeks
Other Name: Paclitaxel

Detailed Description:

Patients will receive study drug every 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084876

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

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01084876     History of Changes
Other Study ID Numbers: CT-P6/3.1
Study First Received: March 9, 2010
Last Updated: August 8, 2013
Health Authority: Singapore: Health Sciences Authority
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014