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 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate
Outcome Description:
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
GPMBC301
NCT ID:
NCT00876486
Start Date:
December 2008
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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