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
1 other identifier
interventional
213
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 1, 2017
April 1, 2017
4.2 years
April 3, 2009
April 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
6 months
Secondary Outcomes (2)
Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response
Event driven
Safety and toxicity
Throughout study
Study Arms (2)
Genexol®-PM
EXPERIMENTALThis 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).
Genexol®
ACTIVE COMPARATORThis 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
December 1, 2008
Primary Completion
February 1, 2013
Study Completion
November 1, 2013
Last Updated
May 1, 2017
Record last verified: 2017-04