Sign in

NCT03315364Active, not recruitingPhase 2/3

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

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
549 (actual)
First submitted
28 Sept 2017
Start date
18 Dec 2017
Primary completion date
19 Feb 2024
Lead sponsor
Daehwa Pharmaceutical Co., Ltd.
NCT number
NCT03315364

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 549
  • From 18 Dec 2017 to the primary completion date, 19 Feb 2024
  • 51 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department
Coordinator of this site? Confirm its status
BurgasBulgariaUnknown status
Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department
Coordinator of this site? Confirm its status
PanagyurishteBulgariaUnknown status
Medical Center Nadezhda Clinical" Ltd.,
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
First Affiliated Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
West China School Of Medicine Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The First Affiliated Hospital Of Hainan Medical College
Coordinator of this site? Confirm its status
HaikouChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Anhui Cancer Hospital
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
Shangdong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
LinYi Cancer Hospital
Coordinator of this site? Confirm its status
LinyiChinaUnknown status
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Jiangsu Cancer Hospital
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Liaoning Cancer Hospital
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
Tianjin Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
Tolna County Balassa Janos Hospital
Coordinator of this site? Confirm its status
SzekszárdHungaryUnknown status
Szent Borbála Hospital
Coordinator of this site? Confirm its status
TatabányaHungaryUnknown status
Kosin University Gospel Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Inje University Haeundae Paik Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Chungbuk National University Hospital
Coordinator of this site? Confirm its status
Cheongju-siSouth KoreaUnknown status
Keimyung University - Dongsan Medical Center
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Konyang University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
Gang Neung Asan Hospital
Coordinator of this site? Confirm its status
GangneungSouth KoreaUnknown status
National Cancer Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Gachon University Gil Medical Center
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
Cha University Cha Bundang Medical Center
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Gangnam Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Catholic University of Korea Seoul ST. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Guro Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Yonsei University Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Ajou University Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaUnknown status
Uijeongbu ST. Mary's Hospital
Coordinator of this site? Confirm its status
Uijeongbu-siSouth KoreaUnknown status
Wonju Severance Christian Hospital
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaUnknown status
Clinical Hospital Center Bežanijska Kosa, Department of Oncology
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
Institute for Oncology and Radiology of Serbia
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
Oncology Institute of Vojvodina
Coordinator of this site? Confirm its status
KamenitzSerbiaUnknown status
Health Center Kladovo, Oncology Department
Coordinator of this site? Confirm its status
KladovoSerbiaUnknown status
Clinical Center Kragujevac Center of Oncology and Radiotherapy
Coordinator of this site? Confirm its status
KragujevacSerbiaUnknown status
General Hospital Krusevac, Outpatient Clinic for chemotherapy
Coordinator of this site? Confirm its status
KruševacSerbiaUnknown status
Clinical Center Niš, Clinic for Oncology
Coordinator of this site? Confirm its status
NišSerbiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.