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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]Genor Biopharma Co., Ltd. [2]Anhui Provincial Cancer Hospital Hefei, Anhui, China, 230031 [3]The Second Hospital of Anhui Medical University Hefei, Anhui, China, 230601 [4]Beijing Chaoyang Hospital of Capital Medical University Beijing, Beijing, China, 100020 [5]Cancer hospital Chinese Academy of Medical Sciences Beijing, Beijing, China, 100021 [6]Chinese PLA General Hospital Beijing, Beijing, China, 100039 [7]Beijing Tiantan Hospital , Capital Medical University Beijing, Beijing, China, 100050 [8]Chongqing University Cancer Hospital Chongqing, Chongqing, China, 400030 [9]The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing, China, 400042 [10]Chognqing University Three Gorges Hospital Chongqing, Chongqing, China, 404000 [11]Fujian Medical University Union Hospital Fuzhou, Fujian, China, 350001 [12]First Affiliated Hospital of Xiamen University Xiamen, Fujian, China, 361003 [13]The First people's hospital of Foshan Foshan, Guangdong, China, 528000 [14]Sun Yat-sen University Cancer Center Guangzhou, Guangdong, China, 510060 [15]The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China, 510080 [16]Guangdong provincial TCM hospital Guangzhou, Guangdong, China, 510120 [17]Meizhou People's Hospital Meizhou, Guangdong, China, 514031 [18]Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital Shenzhen, Guangdong, China, 518172 [19]Hainan General Hospital Haikou, Hainan, China, 570311 [20]Hainan Third People's Hospital Sanya, Hainan, China, 572000 [21]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 50011 [22]Affiliated hospital of Hebei University Shijiazhuang, Hebei, China, 500311 [23]Harbin Medcial Univercity cancer hospital Haerbin, Heilongjiang, China, 150081 [24]Henan Cancer Hospital Zhengzhou, Henan, China, 450003 [25]The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052 [26]Tongji Medical College of Huazhong University of Science and Technology Wuhan, Hubei, China, 430022 [27]Renmin Hospital of Wuhan University Wuhan, Hubei, China, 430060 [28]Hubei Cancer Hospital Wuhan, Hubei, China, 430079 [29]The Affiliated hospital of Inner Mongolia Medical University Hohhot, Inner Mongolia, China, 750306 [30]Jiangsu Province Hospital Nanjing, Jiangsu, China, 210029 [31]Jiangxi Provincial Hospital Nanchang, Jiangxi, China, 330029 [32]Jilin Cancer Hospital Changchun, Jilin, China, 130012 [33]The Second Hospital of Jilin University Changchun, Jilin, China, 130041 [34]Bethune First Hospital Of Jilin University Changchun, Jillin, China, 130061 [35]Shengjing Hospital of China Medical University Shenyang, Liaoning, China, 110022 [36]Liaoning Cancer hospital & Institute Shenyang, Liaoning, China, 110801 [37]General Hospital of Ningxia Medical University Yinchuan, Ningxia, China, 750003 [38]Central Hospital Affiliated to Shandong First Medical University Jinan, Shandong, China, 250013 [39]Shandong Provincial Qianfoshan Hospital Jinan, Shandong, China, 250013 [40]Shandong Provincial Hospital Jinan, Shandong, China, 250021 [41]Shandong Cancer Hospital Jinan, Shandong, China, 250117 [42]Affiliated hospital of Jining Medical University Jining, Shandong, China, 272007 [43]Liaocheng People's Hospital Liaocheng, Shandong, China, 252004 [44]The Affiliated Hospital of Qingdao University Qingdao, Shandong, China, 266003 [45]Taian City Central Hospital Taian, Shandong, China, 271099 [46]Yantai Yuhuangding Hospital Yantai, Shandong, China, 264099 [47]Zhongshan Hospital Fudan University Shanghai, Shanghai, China, 200030 [48]The first hospital of Shanxi Medical University Taiyuan, Shanxi, China, 003001 [49]West China School of Medicine Chengdu, Sichuan, China, 610044 [50]Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin, China, 300181 [51]Affiliated Cancer Hospital of Xinjiang Medical University Urumqi, Xinjiang, China, 830011 [52]The Third Affiliated Hospital of Kunming Medical University Kunming, Yunnan, China, 650118 [53]The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang, China, 310003 [54]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310005 [55]The First Affiliated Hospital of Bengbu Medical College Bengbu, Anhui, China, 233099

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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