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河北医科大学第四医院[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
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.