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

This study is currently recruiting participants.

Verified June 2012 by Samyang Biopharmaceuticals Corporation

Sponsor:

Information provided by (Responsible Party):

Samyang Biopharmaceuticals Corporation

ClinicalTrials.gov Identifier:

NCT00876486

First received: April 3, 2009

Last updated: June 10, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 3, 2009
Last Updated Date	June 10, 2012
Start Date ^ICMJE	December 2008
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2012)	Objective Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ] Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00876486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 10, 2012)	Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response [ Time Frame: Event driven ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: Yes ] To compare the safety and toxicity of Genexol®-PM with those of Genexol®
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
Official Title ^ICMJE	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
Brief Summary	Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	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
Study Arm (s)	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®
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	212
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects should meet all of the following criteria to participate in the trial. Subjects who aged 18 years or older. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis. 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. Subjects who have measurable disease in accordance with the RECIST criteria
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00876486
Other Study ID Numbers ^ICMJE	GPMBC301
Has Data Monitoring Committee	No
Responsible Party	Samyang Biopharmaceuticals Corporation
Study Sponsor ^ICMJE	Samyang Biopharmaceuticals Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samyang Biopharmaceuticals Corporation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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