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
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:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
Outcome Time Frame:
Korea: Food and Drug Administration
- Breast Cancer
- Breast Neoplasms