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

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 III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® 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