Recurrent or Metastatic Breast Cancer
Conditions
Keywords
Breast Cancer, DHP107, Paclitaxel, Liporaxel
Brief summary
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.
Interventions
DRUGDHP107
DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
DRUGIV Paclitaxel
IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
Sponsors
Daehwa Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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). Key
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | Every 8 weeks upto 18 months from randomization date | ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | Up to 18 months from randomization date | PFS is defined as the time from date of randomization until the date of first documented progression or death. |
| Overall survival(OS) | Up to 36 months from FPI | OS is defined as the time from the date of inclusion to the date of death. |
| Time to treatment failure(TTF) | Up to 18 months from randomization date | TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause. |
| Quality of life(QoL) | after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months | Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) |
| Disease control rate(DCR) | Up to 18 months from randomization date | DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization. |
| PK | The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1 | Pharmacokinetics is defined as the study of the time course of drug absorption, distribution, metabolism, and excretion. |
| Duration of response(DOR) | Up to 18 months from randomization date | DOR is the time between the initial response to therapy and subsequent disease progression or relapse. |
Countries
Czechia, United States
Outcome results
None listed