Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Genexol-PM® Type: Drug
Name: Genexol® Type: Drug
Overall Status
Recruiting
Summary
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Sunwoo Park - 82-31-920-1228 - sophie486@lycos.co.kr
Start Date
December 2008
Completion Date
December 2012
Sponsors
Samyang Biopharmaceuticals Corporation
Source
Samyang Biopharmaceuticals Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page