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.
- Diseases
- Metastatic breast cancer
- 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
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department Coordinator of this site? Confirm its status | Burgas | Bulgaria | Unknown status |
| Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department Coordinator of this site? Confirm its status | Panagyurishte | Bulgaria | Unknown status |
| Medical Center Nadezhda Clinical" Ltd., Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| First Affiliated Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China School Of Medicine Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Of Hainan Medical College Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang University School of Medicine, Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Cancer Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shangdong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Tolna County Balassa Janos Hospital Coordinator of this site? Confirm its status | Szekszárd | Hungary | Unknown status |
| Szent Borbála Hospital Coordinator of this site? Confirm its status | Tatabánya | Hungary | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Konyang University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Gang Neung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Cha University Cha Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Catholic University of Korea Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Uijeongbu ST. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Clinical Hospital Center Bežanijska Kosa, Department of Oncology Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Institute for Oncology and Radiology of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Oncology Institute of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| Health Center Kladovo, Oncology Department Coordinator of this site? Confirm its status | Kladovo | Serbia | Unknown status |
| Clinical Center Kragujevac Center of Oncology and Radiotherapy Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| General Hospital Krusevac, Outpatient Clinic for chemotherapy Coordinator of this site? Confirm its status | Kruševac | Serbia | Unknown status |
| Clinical Center Niš, Clinic for Oncology Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.