Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
- Conditions
- Recurrent or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT03326102
- Lead Sponsor
- Daehwa Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DHP107 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. IV paclitaxel IV Paclitaxel Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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)
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.
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.
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.
Trial Locations
- Locations (15)
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)
🇨🇿Hořovice, K Nemocnici, Czechia
Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)
🇨🇿Olomouc, I.P. Pavlova 6, Czechia
Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)
🇨🇿Praha 2, U Nemocnice 499/2, Czechia
California Research Institute (CRI)
🇺🇸Los Angeles, California, United States
Boca Raton Regional Hospital (BRRH)
🇺🇸Boca Raton, Florida, United States
Michigan Center of Medical Research(MCMR)
🇺🇸Farmington Hills, Michigan, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
🇺🇸Minneapolis, Minnesota, United States
Nevada Cancer Research Foundation (NCRF)
🇺🇸Las Vegas, Nevada, United States
University of Pittsburgh Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
ASCLEPES Research Center(ARC)
🇺🇸Weeki Wachee, Florida, United States
University of Kansas Medical Center(KUMC)
🇺🇸Kansas City, Kansas, United States
Anne Arundel Health System Research Institute (AAHS)
🇺🇸Annapolis, Maryland, United States
Massachusetts General Hospital(MGH)
🇺🇸Boston, Massachusetts, United States
Saint Luke's Cancer Institute(SLCI)
🇺🇸Kansas City, Kansas, United States