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A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

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研究单位: [1]Pfizer [2]The First Affiliated Hospital of Anhui Medical University Hefei, Anhui, China, 230022 [3]Fujian Medical University Union Hospital/Medical Oncology Department Fuzhou, Fujian, China, 350001 [4]Sun Yat-Sen University Cancer Center Guangzhou, Guangdong, China, 510060 [5]Zhongshan Ophthalmic Center,Sun Yat-Sen University Guangzhou, Guangdong, China, 510060 [6]Guangdong Provincial People's Hospital Guangzhou, Guangdong, China, 510080 [7]Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou, Guangdong, China, 510120 [8]Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011 [9]Harbin Medical University Cancer Hospital/Oncology Department Harbin, Heilongjiang, China, 150081 [10]Henan Cancer Hospital Zhengzhou, Henan, China, 450008 [11]Hubei Cancer Hospital Wuhan, Hubei, China, 430079 [12]The Second Xiangya Hospital of Central South University Changsha, Hunan, China, 410011 [13]Hunan Provincial Tumor Hospital/Breast Internal Medicine Department Changsha, Hunan, China, 410013 [14]Jiangsu Cancer Hospital Nanjing, Jiangsu, China, 210009 [15]Jiangsu Province Hospital Nanjing, Jiangsu, China, 210029 [16]The first hospital of jilin university Changchun, Jilin, China, 130021 [17]Jilin Provincial Cancer Hospital Changchun, Jilin, China, 130103 [18]The First Hospital of China Medical University/Oncology Department Shenyang, Liaoning, China, 110001 [19]Liaoning Province Cancer Hospital Shenyang, Liaoning, China, 110042 [20]Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China, 200025 [21]West China Hospital of Sichuan University Chengdu, Sichuan, China, 610041 [22]Tianjin Cancer Hospital/Breast cancer department Tianjin, Tianjin, China, 300060 [23]The Tumor Hospital of Yunnan Province Kunming, Yunnan, China, 650118 [24]The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou, Zhejiang, China, 310003 [25]Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology Hangzhou, Zhejiang, China, 310016 [26]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022 [27]Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 [28]307 Hospital of PLA Beijing, China, 100071 [29]Beijing Cancer Hospital Beijing, China, 100142 [30]Peking University Third Hospital/Department of Oncology Beijing, China, 100191 [31]Chinese PLA General Hospital/Oncology Beijing, China, 100853 [32]Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA Chongqing City, China, 400037 [33]Fudan University Shanghai Cancer Center Shanghai, China, 200032 [34]Department of Clinical Oncology Block R Hong Kong, Hong Kong [35]Queen Mary Hospital Hong Kong, Hong Kong [36]Queen Mary Hospital HongKong, Hong Kong [37]Raffles Cancer Centre Singapore, Singapore, 188770 [38]Parkway Cancer Centre Singapore, Singapore, 258500 [39]Tan Tock Seng Hospital Singapore, Singapore, 308433 [40]Tan Tock Seng Hospital Singapore, Singapore, 308442 [41]China Medical University Hospital Taichung, Taiwan, 40447 [42]National Cheng Kung University Hospital / Internal Medicine Tainan, Taiwan, 704 [43]National Taiwan University Hospital Taipei, Taiwan, 100 [44]Mackay Memorial Hospital Taipei, Taiwan, 10449 [45]Taipei Medical University Hospital/ Department of Surgery Taipei, Taiwan, 110 [46]Taipei Veterans General Hospital/Surgery Department Taipei, Taiwan, 11217 [47]Koo Foundation, Sun Yat-Sen Cancer Center Taipei, Taiwan, 11259 [48]Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University ) Taipei, Taiwan, 116 [49]King Chulalongkorn Memorial Hospital Pathumwan, Bangkok, Thailand, 10330 [50]Chula Clinical Research Center (Chula CRC) Patumwan, Bangkok, Thailand, 10330 [51]Division of Therapeutic Radiology and Oncology, Department of Radiology Muang, Chiang MAI, Thailand, 50200 [52]Department of Medicine, Faculty of Medicine, Naresuan University Muang, Phitsanulok, Thailand, 65000 [53]Ramathibodi Hospital, Mahidol University Bangkok, Ratchathevi, Thailand, 10400 [54]Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital Bangkok, Thailand, 10400 [55]Division of Medical Oncology, Department of Medicine, Bangkok, Thailand, 10700 [56]The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department Bengbu, Anhui, China, 233004

关键词: breast cancer postmenopausal women estrogen-receptor positive HER2 negative locoregionally recurrent metastatic

研究目的:
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

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