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A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

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研究单位: [1]Hoffmann-La Roche [2]Long Beach Memorial Medical Center,Fountain Valley,California,United States,92708 [3]Orange Coast Memorial Medical Center,Fountain Valley,California,United States,92708 [4]Kaiser Permanente - San Leandro Medical Center,San Leandro,California,United States,94577 [5]Stanford Univ Medical Center,Stanford,California,United States,94305 [6]Kaiser Permanente - Vallejo,Vallejo,California,United States,94589 [7]Kaiser Permanente - Walnut Creek,Walnut Creek,California,United States,94596 [8]University of Colorado,Aurora,Colorado,United States,80045-2517 [9]Rocky Mountain Cancer Center,Denver,Colorado,United States,80218 [10]Florida Cancer Specialists - Fort Myers (Broadway),Fort Myers,Florida,United States,33901 [11]Memorial Regional Cancer Ctr,Hollywood,Florida,United States,33021 [12]University of Miami [13]Dept Sylvester Cancer Center,Miami,Florida,United States,33136 [14]SCRI Florida Cancer Specialists North [15]Research Office North Region.,Saint Petersburg,Florida,United States,33705 [16]SCRI Florida Cancer Specialists PAN,Tallahassee,Florida,United States,32308 [17]Kaiser Permanente - Moanalua Medical Center,Honolulu,Hawaii,United States,96819-1469 [18]Mercy Medical Center,Baltimore,Maryland,United States,21202 [19]Maryland Oncology Hematology [20]Maryland Oncology Hematology, PA,Silver Spring,Maryland,United States,20902 [21]Massachusetts General Hospital,Boston,Massachusetts,United States,02114-2621 [22]Beth Israel Deaconess Medical Center,Boston,Massachusetts,United States,02215 [23]HCA Midwest Division,Kansas City,Missouri,United States,64132 [24]Memorial Sloan Kettering Cancer Center Basking Ridge,Basking Ridge,New Jersey,United States,07920 [25]Astera Cancer Care East Brunswick,East Brunswick,New Jersey,United States,08816 [26]Memorial Sloan Kettering - Monmouth,Middletown,New Jersey,United States,07748 [27]Memorial Sloan Kettering Cancer Center at Bergen,Montvale,New Jersey,United States,07645 [28]San Juan Oncology Associates,Farmington,New Mexico,United States,87401 [29]MSKCC @ Commack,Commack,New York,United States,11725 [30]Memorial Sloan Kettering Cancer Center at Westchester,Harrison,New York,United States,10604 [31]Memorial Sloan Kettering Cancer Center,New York,New York,United States,11101 [32]Memorial Sloan Kettering Cancer Center at Nassau,Uniondale,New York,United States,11553 [33]The Cleveland Clinic Foundation,Cleveland,Ohio,United States,44195 [34]Providence Portland Medical Ctr,Portland,Oregon,United States,97225 [35]Roper St. Francis Healthcare,Charleston,South Carolina,United States,29414 [36]West Cancer Center,Germantown,Tennessee,United States,38138 [37]Sarah Cannon Research Inst.,Nashville,Tennessee,United States,37203 [38]Harrington Cancer Center,Amarillo,Texas,United States,79106 [39]Texas Oncology-Baylor Sammons Cancer Center,Dallas,Texas,United States,75246 [40]Renovatio Clinical - El Paso,El Paso,Texas,United States,79915 [41]Texas Oncology, P.A. - Fort Worth,Fort Worth,Texas,United States,76104 [42]The Center for Cancer and Blood Disorders - Fort Worth,Fort Worth,Texas,United States,76104 [43]Baylor St. Luke's Medical Center,Houston,Texas,United States,77030 [44]Houston Methodist Hospital,Houston,Texas,United States,77030 [45]Renovatio Clinical,The Woodlands,Texas,United States,77380 [46]Inova Fairfax Hospital,Falls Church,Virginia,United States,22031 [47]Virginia Oncology Associates,Norfolk,Virginia,United States,23502 [48]Northwest Medical Specialties,Tacoma,Washington,United States,98405 [49]University of Wisconsin,Madison,Wisconsin,United States,53705 [50]Fundación CENIT para la Investigación en Neurociencias,Buenos Aires,Argentina,C1125ABD [51]Hospital Britanico,Ciudad Autonoma Bs As,Argentina,C1280AEB [52]Organización medica de Investi,Ciudad Autonoma Buenos Aires,Argentina,C1012AAR [53]Hospital de Onc Angel Roffo,Ciudad Autonoma Buenos Aires,Argentina,C1417DTB [54]Instituto de Oncología de Rosario,Rosario,Argentina,S2000KZE [55]Hospital Provincial del Centenario,Rosario,Argentina,S2002KDS [56]CEMER Centro Medico de Enfermedades Respiratorias,Vicente López,Argentina,B1602DQD [57]Calvary Mater Newcastle [58]Medical Oncology,Waratah,New South Wales,Australia,2298 [59]Mater Hospital Brisbane,South Brisbane,Queensland,Australia,4101 [60]Princess Alexandra Hospital [61]Division of Cancer Services,Woolloongabba,Queensland,Australia,4102 [62]Flinders Medical Centre [63]Medical Oncology,Bedford Park,South Australia,Australia,5042 [64]Peter MacCallum Cancer Centre-East Melbourne,Melbourne,Victoria,Australia,3000 [65]Sunshine Hospital,St Albans,Victoria,Australia,3021 [66]Fiona Stanley Hospital - Medical Oncology,Murdoch,Western Australia,Australia,6150 [67]Uniklinikum Salzburg, LKH [68]Univ.Klinik f. Innere Medizin III der PMU,Salzburg,Austria,5020 [69]A.Ö. Lhk [70]Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie,Steyr,Austria,4400 [71]Medizinische Universität Wien [72]Univ.Klinik für Innere Medizin I,Wien,Austria,1090 [73]Cliniques Universitaires St-Luc,Bruxelles,Belgium,1200 [74]Jessa Zkh (Campus Virga Jesse),Hasselt,Belgium,3500 [75]Hospital Sao Rafael - HSR,Salvador,BA,Brazil,41253-190 [76]Hospital Araujo Jorge [77]Departamento de Ginecologia E Mama,Goiania,GO,Brazil,74605-070 [78]Hospital do Cancer de Pernambuco - HCP,Recife,PE,Brazil,50040-000 [79]Santa Casa de Misericordia de Porto Alegre,Porto Alegre,RS,Brazil,90020-090 [80]Hospital Sao Lucas - PUCRS,Porto Alegre,RS,Brazil,90610-000 [81]Hospital de Base de Sao Jose do Rio Preto,Sao Jose do Rio Preto,SP,Brazil,15090-000 [82]Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda,Sao Paulo,SP,Brazil,01317-001 [83]Beneficencia Portuguesa de Sao Paulo,São Paulo,SP,Brazil,01321-00 [84]Tom Baker Cancer Centre-Calgary,Calgary,Alberta,Canada,T2N 4N2 [85]BC Cancer ? Surrey,Surrey,British Columbia,Canada,V3V 1Z2 [86]Royal Victoria Regional Health Centre,Barrie,Ontario,Canada,L4M 6M2 [87]William Osler Health System Brampton Civic Hospital,Brampton,Ontario,Canada,L6R 3J7 [88]Ottawa Hospital Research Institute,Ottawa,Ontario,Canada,K1Y 4E9 [89]Princess Margaret Cancer Center,Toronto,Ontario,Canada,M5G 1Z5 [90]Universite de Montreal - Hopital Maisonneuve-Rosemont,Montreal,Quebec,Canada,H1T 2M4 [91]Centre Hospitalier de l?Université de Montréal (CHUM),Montreal,Quebec,Canada,H2X 0C2 [92]Jewish General Hospital,Montreal,Quebec,Canada,H3T 1E2 [93]McGill University Health Center,Montreal,Quebec,Canada,H4A 3J1 [94]Hopital du Saint Sacrement,Quebec City,Quebec,Canada,G1S 4L8 [95]Anyang Tumor Hosptial,Anyang City,China,455000 [96]Affiliated Hospital of Hebei University [97]Department of medical oncology,Baoding,China,071000 [98]Peking University People's Hospital,Beijing,China,100044 [99]Beijing Cancer Hospital,Beijing,China,100142

研究目的:
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

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