Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Purpose
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.
Condition
- Recurrent or Metastatic Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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).
Exclusion Criteria
- Subjects who have received prior taxane therapy in the metastatic setting 2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study. 3. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry 4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening. 5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be assigned to DHP107 or IV paclitaxel in a ratio of 2:1 (n=48 to DHP107 and n=24 to IV paclitaxel)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental DHP107 |
The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days. |
|
Experimental IV paclitaxel |
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off) |
|
More Details
- Status
- Completed
- Sponsor
- Daehwa Pharmaceutical Co., Ltd.