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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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).

Exclusion Criteria

  1. 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

ArmDescriptionAssigned 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.
  • Drug: DHP107
    DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
    Other names:
    • Liporaxel®, Oral Paclitaxel
Experimental
IV paclitaxel
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
  • Drug: IV Paclitaxel
    IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
    Other names:
    • Taxol Injection

More Details

Status
Completed
Sponsor
Daehwa Pharmaceutical Co., Ltd.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.