1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination

2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples

3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting

4. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.

5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer