Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
NCT ID: NCT00876486
Last Updated: 2017-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2008-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Genexol-PM®
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
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).
Genexol®
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
Interventions
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Genexol-PM®
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
Genexol®
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Samyang Biopharmaceuticals Corporation
INDUSTRY
Responsible Party
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Locations
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National Cancer Center
Goyang-si, Gyeonggi-do, , South Korea
Countries
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Other Identifiers
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GPMBC301
Identifier Type: -
Identifier Source: org_study_id
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