Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03315364
PHASE2/PHASE3

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

Sponsor: Daehwa Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

549

Start Date

2017-12-18

Completion Date

2028-11-30

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Oral paclitaxel

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

DRUG

Paclitaxel injection

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

Locations (51)

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, China

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital Of Hainan Medical College

Haikou, Hainan, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Tianjin Cancer Hospital

Zhengzhou, Henan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shangdong Cancer Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong university

Xi’an, Shanxi, China

West China School Of Medicine Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Zhejiang University School Of Medicine Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

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, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Cha University Cha Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

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

Gang Neung Asan Hospital

Gangneung, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei University Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Catholic University of Korea Seoul ST. Mary's Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Uijeongbu ST. Mary's Hospital

Uijeongbu-si, South Korea