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Clinical Trials in South Korea / NCT03315364
Active, not recruiting Phase 2/3

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

NCT03315364 · tracked via the Priya Life Science South Korea tracker
Sponsor
Daehwa Pharmaceutical Co., Ltd
Phase
Phase 2/3
Started
2017-12-18
Last updated
2026-04-01

Condition(s) studied

Recurrent or Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Oral paclitaxel →Paclitaxel injection →

Oral paclitaxel: Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Paclitaxel injection: Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Study summary

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Key inclusion/exclusion criteria * Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer. * Measurable disease (revised RECIST, version 1.1). * Hormone receptor (ER/PR) positive or negative, HER2 negative. * Subjects were eligible for the study regardless of their previous lines of endocrine therapy. * No prior chemotherapy is allowed in metastatic disease. * Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day. * ECOG performance status ≤1. * Neuropathy grade \<2. * Subjects with central nervous system metastasis should be excluded.

Primary outcome measure(s)

  • [Phase II] Objective Response Rate (ORR) — Participants will be followed every 6 weeks until progression, an expected average of 9 months.
    Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
  • [Phase III] Progression Free Survival (PFS) — From date of randomization, assessed up to 18 months.
    Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

Trial sites (51)

FacilityCityRegionStatus
Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department Burgas Bulgaria
Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department Panagyurishte Bulgaria
Medical Center Nadezhda Clinical" Ltd., Sofia Bulgaria
Anhui Cancer Hospital Hefei Anhui
Cancer Hospital Chinese Academy Of Medical Sciences Beijing Beijing Municipality
Sun Yat-sen University Cancer Center Guangzhou Guangdong
The First Affiliated Hospital Of Hainan Medical College Haikou Hainan
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Tianjin Cancer Hospital Zhengzhou Henan
Jiangsu Cancer Hospital Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
First Affiliated Hospital of Jilin University Changchun Jilin
Liaoning Cancer Hospital Shenyang Liaoning
Shangdong Cancer Hospital Jinan Shandong
Linyi Cancer Hospital Linyi Shandong
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
The First Affiliated Hospital of Xi'an Jiaotong university Xi’an Shanxi
West China School Of Medicine Sichuan University Chengdu Sichuan
Zhejiang Cancer Hospital Hangzhou Zhejiang
Zhejiang University School Of Medicine Sir Run Run Shaw Hospital Hangzhou Zhejiang
Henan Cancer Hospital Zhengzhou China
Tolna County Balassa János Hospital Szekszárd Hungary
Szent Borbála Hospital Tatabánya Hungary
Institute for Oncology and Radiology of Serbia Belgrade Serbia
Clinical Hospital Center Bežanijska Kosa, Department of Oncology Belgrade Serbia
Oncology Institute of Vojvodina Kamenitz Serbia
Health Center Kladovo, Oncology Department Kladovo Serbia
Clinical Center Kragujevac Center of Oncology and Radiotherapy Kragujevac Serbia
General Hospital Krusevac, Outpatient Clinic for chemotherapy Kruševac Serbia
Clinical Center Niš, Clinic for Oncology Niš Serbia
Wonju Severance Christian Hospital Wŏnju Gangwon-do
National Cancer Center Goyang-si Gyeonggi-do
Cha University Cha Bundang Medical Center Seongnam-si Gyeonggi-do
Ajou University Hospital Suwon Gyeonggi-do
Chungbuk National University Hospital Cheongju-si North Chungcheong
Inje University Haeundae Paik Hospital Busan South Korea
Kosin University Gospel Hospital Busan South Korea
Pusan National University Yangsan Hospital Busan South Korea
Keimyung University Dongsan Medical Center Daegu South Korea
Konyang University Hospital Daejeon South Korea

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03315364 on ClinicalTrials.gov ↗ ← All trials in South Korea