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Spots Global Cancer Trial Database for A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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