A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
研究单位：[1]Hoffmann-La Roche[2]Kaiser Permanente - Harbor City,Harbor City,California,United States,90710[3]USC Norris Comprehensive Cancer Center,Los Angeles,California,United States,90033[4]USC Norris Cancer Center[5]Oncology/Hematology - Newport Beach Treatment Center,Newport Beach,California,United States,92663[6]New England Cancer Specialists,Scarborough,Maine,United States,04074[7]Frederick Health Hospital,Frederick,Maryland,United States,21701[8]Astera Cancer Care East Brunswick,East Brunswick,New Jersey,United States,08816[9]Asante Rogue Regional Medical Center,Medford,Oregon,United States,97504-8332[10]Ann B. Barshinger Cancer Institute,Lancaster,Pennsylvania,United States,17604[11]West Cancer Center,Germantown,Tennessee,United States,38138[12]Fundación CENIT para la Investigación en Neurociencias,Buenos Aires,Argentina,C1125ABD[13]Inst. De Oncologia Angel H. Roffo[14]Oncology Dept,Buenos aires,Argentina,C1417DTB[15]Centro Oncologico Korben[16]Oncology,Ciudad Autonoma Buenos Aires,Argentina,C1426AGE[17]Sanatorio Allende,Cordoba,Argentina,X5000JHQ[18]Centro Oncologico Riojano Integral (CORI),La Rioja,Argentina,F5300COE[19]Hospital Alemán,Recoleta,Argentina,C1118AAT[20]Instituto de Oncología de Rosario,Rosario,Argentina,S2000KZE[21]Sanatorio Parque S.A.,Rosario,Argentina,S2000QGB[22]Hospital Provincial del Centenario,Rosario,Argentina,S2002KDS[23]Centro Oncológico de Excelencia,San Juan,Argentina,J5400[24]Northern Beaches Hospital,Frenchs Forest,New South Wales,Australia,2086[25]Nepean Hospital[26]Nepean Cancer Care Centre,Kingswood,New South Wales,Australia,2747[27]Mater Hospital[28]Patricia Ritchie Centre for Cancer Care and Research,North Sydney,New South Wales,Australia,2060[29]University of the Sunshine Coast,Sippy Downs,Queensland,Australia,4556[30]Mater Misericordiae Limited,South Brisbane,Queensland,Australia,4101[31]Cancer Research SA,Adelaide,South Australia,Australia,5000[32]Barwon Health,Geelong,Victoria,Australia,3220[33]Sunshine Hospital,St Albans,Victoria,Australia,3021[34]South West Healthcare,Warrnambool,Victoria,Australia,3280[35]Cliniques Universitaires St-Luc,Bruxelles,Belgium,1200[36]UZ Gent,Gent,Belgium,9000[37]UZ Leuven Gasthuisberg,Leuven,Belgium,3000[38]Clinique Ste-Elisabeth,Namur,Belgium,5000[39]Sint Augustinus Wilrijk,Wilrijk,Belgium,2610[40]Obras Sociais Irma Dulce - Osid,Salvador,BA,Brazil,40415-006[41]CEDOES - Diagnóstico e Pesquisa,Vitoria,ES,Brazil,29055-450[42]Hospital do Cancer de Pernambuco - HCP,Recife,PE,Brazil,50040-000[43]Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda,Ijui,RS,Brazil,98700-000[44]Santa Casa de Misericordia de Porto Alegre,Porto Alegre,RS,Brazil,90020-090[45]Hospital Moinhos de Vento,Porto Alegre,RS,Brazil,90035-000[46]Hospital Sao Lucas - PUCRS,Porto Alegre,RS,Brazil,90610-000[47]Hospital de Cancer de Barretos,Barretos,SP,Brazil,14784-400[48]Hospital Sírio-Libanês,Sao Paulo,SP,Brazil,01308-050[49]Hospital A. C. Camargo[50]Oncologia,Sao Paulo,SP,Brazil,01509-010[51]Royal Victoria Regional Health Centre,Barrie,Ontario,Canada,L4M 6M2[52]Lakeridge Health Oshawa,Oshawa,Ontario,Canada,L1G 2B9[53]North York General Hospital,Toronto,Ontario,Canada,M2K 1E1[54]CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital,Chicoutimi,Quebec,Canada,G7H 5H6[55]Centre Hospitalier de l'Universite de Montreal (CHUM),Montreal,Quebec,Canada,H2X 0C1[56]McGill University Health Centre - Glen Site,Montreal,Quebec,Canada,H4A 3J1[57]CHU de Québec - Hôpital du Saint-Sacrement,Quebec City,Quebec,Canada,G1S 4L8[58]Hopital regional de saint jerome,Saint-jerome,Quebec,Canada,J7Z 5T3[59]Clínica Puerto Montt,Puerto Montt,Chile,5500243[60]Oncovida,Santiago,Chile,7510032[61]Centro De Cancer Universidad Catolica,Santiago,Chile,8330032[62]Icegclinic,Santiago,Chile[63]Beijing Cancer Hospital,Beijing,China,100142[64]the First Hospital of Jilin University[65]Cancer Center,Changchun City,China,130021[66]West China Hospital of Sichuan University,Chengdu City,China,610041[67]Sichuan Provincial People's Hospital,Chengdu,China,610072[68]Fujian Medical University Union Hospital,Fuzhou City,China,350001[69]No. 900 Hospital (Fuzhou General Hospital),Fuzhou City,China,350009[70]Cancer Center, Sun Yat-sen University of Medical Sciences[71]Department of Medical Oncology,Guangzhou City,China,510060[72]The Second Affiliated Hospital of Zhejiang University College,Hangzhou,China,310009[73]Harbin Medical University Cancer Hospital,Harbin,China,150081[74]Jinan Central Hospital,Jinan City,China,250013[75]Shandong Cancer Hospital,Jinan,China,250117[76]The First People's Hospital of Yunnan Province,Kunming City,China,650034[77]The First Affiliated Hospital to Henan University of Science and Technology,Luoyang City,China,471031[78]Guangxi Cancer Hospital of Guangxi Medical University,Nanning City,China,530021
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
