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GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

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研究单位: [1]Chinese Academy of Medical Sciences [2]Genor Biopharma Co., Ltd. [3]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China,233099 [4]Anhui Provincial Cancer Hospital,Hefei,Anhui,China,230031 [5]The Second Hospital of Anhui Medical University,Hefei,Anhui,China,230601 [6]Beijing Chaoyang Hospital of Capital Medical University,Beijing,Beijing,China,100020 [7]Cancer hospital Chinese Academy of Medical Sciences,Beijing,Beijing,China,100021 [8]Chinese PLA General Hospital,Beijing,Beijing,China,100039 [9]Beijing Tiantan Hospital , Capital Medical University,Beijing,Beijing,China,100050 [10]Chongqing University Cancer Hospital,Chongqing,Chongqing,China,400030 [11]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400042 [12]Chognqing University Three Gorges Hospital,Chongqing,Chongqing,China,404000 [13]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350001 [14]First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003 [15]The First people's hospital of Foshan,Foshan,Guangdong,China,528000 [16]Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China,510060 [17]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510080 [18]Guangdong provincial TCM hospital,Guangzhou,Guangdong,China,510120 [19]Meizhou People's Hospital,Meizhou,Guangdong,China,514031 [20]Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital,Shenzhen,Guangdong,China,518172 [21]Hainan General Hospital,Haikou,Hainan,China,570311 [22]Hainan Third People's Hospital,Sanya,Hainan,China,572000 [23]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,50011 [24]Affiliated hospital of Hebei University,Shijiazhuang,Hebei,China,500311 [25]Harbin Medcial Univercity cancer hospital,Haerbin,Heilongjiang,China,150081 [26]Henan Cancer Hospital,Zhengzhou,Henan,China,450003 [27]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052 [28]Tongji Medical College of Huazhong University of Science and Technology,Wuhan,Hubei,China,430022 [29]Renmin Hospital of Wuhan University,Wuhan,Hubei,China,430060 [30]Hubei Cancer Hospital,Wuhan,Hubei,China,430079 [31]The Affiliated hospital of Inner Mongolia Medical University,Hohhot,Inner Mongolia,China,750306 [32]Jiangsu Province Hospital,Nanjing,Jiangsu,China,210029 [33]Jiangxi Provincial Hospital,Nanchang,Jiangxi,China,330029 [34]Jilin Cancer Hospital,Changchun,Jilin,China,130012 [35]The Second Hospital of Jilin University,Changchun,Jilin,China,130041 [36]Bethune First Hospital Of Jilin University,Changchun,Jillin,China,130061 [37]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China,110022 [38]Liaoning Cancer hospital & Institute,Shenyang,Liaoning,China,110801 [39]General Hospital of Ningxia Medical University,Yinchuan,Ningxia,China,750003 [40]Central Hospital Affiliated to Shandong First Medical University,Jinan,Shandong,China,250013 [41]Shandong Provincial Qianfoshan Hospital,Jinan,Shandong,China,250013 [42]Shandong Provincial Hospital,Jinan,Shandong,China,250021 [43]Shandong Cancer Hospital,Jinan,Shandong,China,250117 [44]Affiliated hospital of Jining Medical University,Jining,Shandong,China,272007 [45]Liaocheng People's Hospital,Liaocheng,Shandong,China,252004 [46]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China,266003 [47]Taian City Central Hospital,Taian,Shandong,China,271099 [48]Yantai Yuhuangding Hospital,Yantai,Shandong,China,264099 [49]Zhongshan Hospital Fudan University,Shanghai,Shanghai,China,200030 [50]The first hospital of Shanxi Medical University,Taiyuan,Shanxi,China,003001 [51]West China School of Medicine,Chengdu,Sichuan,China,610044 [52]Tianjin Medical University Cancer Institute & Hospital,Tianjin,Tianjin,China,300181 [53]Affiliated Cancer Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China,830011 [54]The Third Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China,650118

关键词: CDK46 Phase III GB491

研究目的:
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.

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