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Brief Title: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
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
Study ID: NCT03315364
Brief Summary: To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Detailed Description:
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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, 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
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Cha University Cha Bundang Medical Center, Seongnam, Gyeonggi-do, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Pusan National University Yangsan Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Konyang University Hospital, Daejeon, , Korea, Republic of
Gang Neung Asan Hospital, Gangneung, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Catholic University of Korea Seoul ST. Mary's Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Uijeongbu ST. Mary's Hospital, Uijeongbu, , Korea, Republic of
Institute for Oncology and Radiology of Serbia, Belgrade, , Serbia
Clinical Hospital Center Bežanijska Kosa, Department of Oncology, Belgrade, , 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
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
Name: Sung-bae Kim, M.D., Ph.D
Affiliation: Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR