Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
- 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).
- 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).
Trial Phase Phase II
Trial Type Treatment
Daehwa Pharmaceutical Co., Ltd.
- Primary ID 107CS-6
- Secondary IDs NCI-2018-01373
- Clinicaltrials.gov ID NCT03326102