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

NCT03315364 · tracked via the Priya Life Science China 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

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)

Facility	City	Region
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 China