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Brief Title: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy
Study ID: NCT05054751
Brief Summary: GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Chaoyang Hospital of Capital Medical University, Beijing, Beijing, China
Cancer hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Beijing Tiantan Hospital , Capital Medical University, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
Chognqing University Three Gorges Hospital, Chongqing, Chongqing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
The First people's hospital of Foshan, Foshan, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Guangdong provincial TCM hospital, Guangzhou, Guangdong, China
Meizhou People's Hospital, Meizhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital, Shenzhen, Guangdong, China
Hainan General Hospital, Haikou, Hainan, China
Hainan Third People's Hospital, Sanya, Hainan, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Affiliated hospital of Hebei University, Shijiazhuang, Hebei, China
Harbin Medcial Univercity cancer hospital, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
The Affiliated hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Jiangxi Provincial Hospital, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The Second Hospital of Jilin University, Changchun, Jilin, China
Bethune First Hospital Of Jilin University, Changchun, Jillin, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer hospital & Institute, Shenyang, Liaoning, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, China
Shandong Provincial Hospital, Jinan, Shandong, China
Shandong Cancer Hospital, Jinan, Shandong, China
Affiliated hospital of Jining Medical University, Jining, Shandong, China
Liaocheng People's Hospital, Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Taian City Central Hospital, Taian, Shandong, China
Yantai Yuhuangding Hospital, Yantai, Shandong, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
The first hospital of Shanxi Medical University, Taiyuan, Shanxi, China
West China School of Medicine, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
The Third Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Name: Binghe Xu, PhD
Affiliation: Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR