Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Paclitaxel

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