Spots Global Cancer Trial Database for Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
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Trial Identification
Brief Title: Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
Official Title: Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer
Study ID: NCT03084237
Conditions
Study Description
Brief Summary: This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
Detailed Description: This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given); thereafter, assessments will be done every 9 weeks (after Cycles 11, 14, and 17) or earlier in the case of clinical signs of progression.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
First Affiliated Hospital of Guangzhou University of TMC, Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Sun Yat-sen University, Cancer Center, Guanzhou, Guangdong, China
The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
Liuzhou General Hospital, Liuzhou, Guangxi, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
Hebei Cangzhou Central Hospital, Cangzhou, Hebei, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China
The 2nd Xiangya Hospital of Central South University, Changsha, Hunan, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Nanjing Bayi Hospital, Nanjing, Jiangsu, China
The Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
Wuxi 4th People's Hospital, Wuxi, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Chang chun, Jilin, China
Jilin Cancer Hospital, Changchun, Jilin, China
Jilin Province People's Hospital, Changchun, Jilin, China
The Second Hospital of Dalian Medical University, Dalian, Liaoning, China
General Hospital of the Northern Theater of the Chinese People's Liberation Army, Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Affiliated Hospital of Qinghai University, Xining, Qinghai, China
Affiliated Hospital of Jining Medical University, Jining, Shandong, China
Jinan Central Hospital, Jinan, Shangdong, China
Yantai Yuhuangding Hospital, Yantai, Shangdong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shannxi Provincial Tumor Hospital, Xi'an, Shangxi, China
The 2nd Hospital of Xi'An Jiaotong University, Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Nanchong Central Hospital, Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjing, Tianjing, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University, HanGzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, , China
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Metro Davao Medical and Research Center, Inc., Davao City, Davao, Philippines
Cardinal Santos Medical Center, San Juan, La Union, Philippines
Manila Doctors Hospital, Manila, Metro Manila, Philippines
The Medical City, Pasig City, Metro Manila, Philippines
Cebu Doctors University Hospital, Cebu City, , Philippines
CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih, Dnepropetrovsk, Ukraine
CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipro, Dnipropetrovsk, Ukraine
CI Carpathian Clinical Oncological Center, Ivano-Frankivs'k, Ivano-Frankivsk, Ukraine
CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU, Uzhgorod, Outer Carpathian, Ukraine
Transcarpathian Regional Clinical Oncological Dispensary, Uzhgorod, Outer Carpathian, Ukraine
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council, Lutsk, Warren, Ukraine
CTPI Chernihiv Regional Oncological Dispensary, Chernihiv, , Ukraine
CI Chernivtsi RC Oncological Dispensary, Chernivtsi, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv, , Ukraine
CI of Kherson Reg Council Kherson Regional Oncologic Dispensary, Kherson, , Ukraine
Khmelnytskyi Regional Oncological Dispensary, Khmelnytskyi, , Ukraine
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus, Kropyvnytskyi, , Ukraine
National Institute of Cancer, Kyiv, , Ukraine
CNE Kyiv City Clin Oncological Center of Ex Body of Kyiv CC(KCSA), Kyiv, , Ukraine
Kyiv Сity Clinical Oncological Center, Kyiv, , Ukraine
CI of LRC Lviv Oncological Regional Treatment and Diagnostic Center, Lviv, , Ukraine
CI Odesa Regional Clinical Hospital, Odesa, , Ukraine
Odesa Regional Oncologic Dispensary, Odesa, , Ukraine
Poltava Reg Cl Onc Dispensary of PRC Chemotherapy Dept HSEI of Ukr UMSA, Poltava, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary Dept of of Chemotherapy Sumy SU, Sumy, , Ukraine
Podilskyi Regional Oncological Center, Vinnytsia, , Ukraine
CI Zaporizhzhia RC Onc Dispensary of ZRC Dept of Breast Pathology SI Zaporizhzhia MA of PGE of MoHU, Zaporizhzhia, , Ukraine
CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC, Zaporizhzhia, , Ukraine
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