We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
First Posted: March 11, 2010
Last Update Posted: February 12, 2015
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.
Information provided by (Responsible Party):
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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

Enrollment: 383
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
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
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

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

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01084876     History of Changes
Other Study ID Numbers: CT-P6/3.1
First Submitted: March 9, 2010
First Posted: March 11, 2010
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Celltrion:
metastatic breast cancer

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