Spots Global Cancer Trial Database for A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Official Title: A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study ID: NCT04924699
Study Description
Brief Summary: The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary objective of Phase III is to evaluate the efficacy and safety of MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have been previously treated with trastuzumab (or a biosimilar) and an anti-HER2 tyrosine kinase inhibitor (anti-HER2-TKI) and have progressed on or after the most recent therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital, Hefei, Anhui, China
Fifth Medical Center of PLA General Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
The Fourth hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hosipital of Zhengzhou University, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Liaoning Cancer Hospital & Institute, Shengyang, Liaoning, China
Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China
Shanghai East Hospital, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital, Tianjing, Tianjing, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Zefei Jiang, Doctor
Affiliation: Fifth Medical Center of PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Yunjinang Liu, Doctor
Affiliation: The Fourth Hospital of Hebei Medical University
Role: PRINCIPAL_INVESTIGATOR
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