A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
• Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
• Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
• Presence of at least one measurable lesion according to RECIST v1.1
• Expected survival time ≥ 12 weeks.
• Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Other Locations
China
Anyang Cancer Hospital
RECRUITING
Anyang
The Affiliated Hospital of Hebei University
RECRUITING
Baoding
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
The Third People's Hospital of Chengdu City
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
The Second Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Deyang People's Hospital
RECRUITING
Deyang
The Affiliated Fuyang Hospital of Anhui Medical University
RECRUITING
Fuyang
Fujian Cancer Hospital
RECRUITING
Fuzhou
Ganzhou Cancer Hospital
RECRUITING
Ganzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Guizhou Medical University Cancer Hospital
RECRUITING
Guiyang
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The Affiliated Hospital of Hebei University of Engineering
RECRUITING
Handan
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First People's Hospital of Hangzhou City
RECRUITING
Hangzhou
The First People's Hospital of Xiaoshan District, Hangzhou City
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Women's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Cancer Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Shandong Cancer Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Jinzhou Medical University
RECRUITING
Jinzhou
Yunnan Cancer Hospital
RECRUITING
Kunming
The Second People's Hospital of Liaocheng City
RECRUITING
Linqing
Linyi Cancer Hospital
RECRUITING
Linyi
Linyi Central Hospital
RECRUITING
Linyi
Luoyang Central Hospital
RECRUITING
Luoyang
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Meizhou People's Hospital
RECRUITING
Meizhou
Nanchang People's Hospital
RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
The Second People's Hospital of Neijiang City
RECRUITING
Neijiang
The Affiliated People's Hospital of Ningbo University
RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Yidu Central Hospital of Weifang City
RECRUITING
Qingzhou
The Second Affiliated Hospital of Fujian Medical University
RECRUITING
Quanzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Shanghai Gaobo Cancer Hospital
RECRUITING
Shanghai
Shantou Central Hospital
RECRUITING
Shantou
Liaoning Cancer Hospital
RECRUITING
Shenyang
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Suining Central Hospital
RECRUITING
Suining
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Cancer Hospital
RECRUITING
Tianjin
Weifang People's Hospital
RECRUITING
Weifang
Hubei Cancer Hospital
RECRUITING
Wuhan
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Xingtai People's Hospital
RECRUITING
Xingtai
The First Affiliated Hospital of Henan Medical University
RECRUITING
Xinxiang
Xuchang Central Hospital
RECRUITING
Xuchang
Xuzhou Central Hospital
RECRUITING
Xuzhou
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Yongzhou Central Hospital
RECRUITING
Yongzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Zhenxing Yang
yangzx@genequantum.com
+86 13801896162
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2028-01-09
Participants
Target number of participants: 228
Treatments
Experimental: GQ1005
GQ1005 will be administered intravenously every 21 days.
Experimental: T-DM1
T-DM1 will be administered intravenously every 21 days.
Related Therapeutic Areas
Sponsors
Leads: GeneQuantum Healthcare (Suzhou) Co., Ltd.