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Brief Title: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
Official Title: A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases
Study ID: NCT03500380
Brief Summary: This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
An Yang Cancer Hospital, Anyang, , China
Beijing Luhe Hospital, Beijing, , China
Peking University People's Hospital, Beijing, , China
The First Affiliated Hospital of Bengbu Medical College, Bengbu, , China
Bin Zhou No.1 People's Hospital, Binzhou, , China
Jilin Cancer Hospital, Changchun, , China
The First Hospital Jilin University, Changchun, , China
The First Hospital of Jilin University, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
The Second Xiyang Hospital of Central South University, Changsha, , China
Xiangya Hospital Central South University, Changsha, , China
Heping Hospital Affiliated to Changzhi Medical College, Changzhi, , China
Affiliated Hospital of Chengde Medical University, Chengde, , China
West China Hospital,Sichuan University, Chengdu, , China
Chongqing University Three gorges Hospital, Chongqing, , China
The Southwest Hospital of AMU, Chongqing, , China
The Second Hospital of Dalian Medical University, Dalian, , China
Fujian Cancer Hospital, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Sun Yat-Sen Memorial Hospital, Guangzhou, , China
The Affiliated Tumor Hospital of Guangzhou Medical University, Guangzhou, , China
Guizhou Cancer Hospital, Guiyang, , China
Harbin Medical University Cancer Hospital, Ha'erbin, , China
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Anhui Cancer Hospital, Hefei, , China
Anhui Province Hospital, Hefei, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
Qilu Hospital of Shandong University, Jinan, , China
The First People's Hospital of Jining, Jining, , China
Yunnan Cancer Hospital, Kunming, , China
Linyi Cancer Hospital, Linyi, , China
The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, , China
Jiangsu Cancer Hospital, Nanjing, , China
The Affiliated Tumor Hospital of Guangxi Medical University, Nanning, , China
The Second People's Hospital of Neijiang, Neijiang, , China
Hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shanghai Changhai Hospital, Shanghai, , China
Shanghai Ruijin Hospital, Shanghai, , China
Cancer Hospital of Shantou University Medical College, Shantou, , China
Yue Bei People's Hospital, Shaoguan, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
Tai'an City Central Hospital, Tai'an, , China
Shanxi Bethune Hospital, Taiyuan, , China
Shanxi Cancer Hospital, Taiyuan, , China
Taizhou Enze Medical Center, Taizhou, , China
Tianjin Cancer Hospitial, Tianjin, , China
Weihai Municipal Hospital, Weihai, , China
Hubei Cancer Hospital, Wuhan, , China
Tongji Medical College of HUST, Wuhan, , China
Wuhan Union Hospital, Wuhan, , China
The First Affiliated Hospital of the Fourth Military University of P.L.A., Xi'an, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
Xing Tai People's Hospital, Xingtai, , China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, , China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Xuzhou Central Hospital, Xuzhou, , China
Yanbian University Hospital, Yanbian, , China
Yantai Yuhuangding Hospital, Yantai, , China
Yuncheng Central Hospital, Yuncheng, , China
Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China