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

Inclusion Criteria

• Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
• Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
• Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
• Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). Key

Exclusion Criteria

• Subjects who have received prior taxane therapy in the metastatic setting
• Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
• Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
• Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
• Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).