Status:
COMPLETED
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00876486
Start Date
December 1 2008
End Date
November 1 2013
Last Update
May 1 2017
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea