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Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876486
First Posted: April 6, 2009
Last Update Posted: May 1, 2017
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):
Samyang Biopharmaceuticals Corporation
April 3, 2009
April 6, 2009
May 1, 2017
December 2008
February 2013   (Final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: 6 months ]
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
Not Provided
Complete list of historical versions of study NCT00876486 on ClinicalTrials.gov Archive Site
  • Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response [ Time Frame: Event driven ]
    To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response.
  • Safety and toxicity [ Time Frame: Throughout study ]
    To compare the safety and toxicity of Genexol®-PM with those of Genexol®
Not Provided
Not Provided
Not Provided
 
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Genexol-PM®
    Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
  • Drug: Genexol®
    Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
  • Experimental: Genexol®-PM
    This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
    Intervention: Drug: Genexol-PM®
  • Active Comparator: Genexol®
    This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
    Intervention: Drug: Genexol®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
November 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects should meet all of the following criteria to participate in the trial.

  1. Subjects who aged 18 years or older.
  2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
  3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
  4. If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
  5. Subjects who have measurable disease in accordance with the RECIST criteria
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00876486
GPMBC301
No
Not Provided
Not Provided
Samyang Biopharmaceuticals Corporation
Samyang Biopharmaceuticals Corporation
Not Provided
Not Provided
Samyang Biopharmaceuticals Corporation
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP