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评估 Capivasertib + 氟维司群对比安慰剂 + 氟维司群治疗局部晚期(不可手术)或转移性乳腺癌的疗效和安全性的研究

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研究单位: [1]复旦大学附属肿瘤医院 [2]浙江省肿瘤医院(浙江省癌症中心) [3]哈尔滨医科大学附属肿瘤医院 [4]吉林大学第一医院 [5]辽宁省肿瘤医院 [6]湖北省肿瘤医院 [7]华中科技大学同济医学院附属同济医院 [8]安徽医科大学第一附属医院 [9]重庆大学附属肿瘤医院(重庆市肿瘤医院、重庆市肿瘤研究所、重庆市癌症中心) [10]天津市肿瘤医院 [11]济南市中心医院 [12]北京大学人民医院 [13]浙江大学医学院附属第一医院 [14]安徽省立医院(中国科学技术大学第一附属医院) [15]四川省肿瘤医院 [16]山东省肿瘤医院 [17]河南省肿瘤医院 [18]中国医科大学附属第一医院 [19]南昌市第三医院 [20]广州医科大学附属肿瘤医院 [21]大连医科大学附属第一医院 [22]北京大学第一医院 [23]上海交通大学医学院附属仁济医院 [24]中国医学科学院肿瘤医院 [25]重庆医科大学附属第一医院 [26]北京大学第三医院 [27]华中科技大学同济医学院附属协和医院 [28]佛山市第一人民医院 [29]河北大学附属医院 [30]西安交通大学第二附属医院 [31]临沂市肿瘤医院 [32]广东省人民医院 [33]内江市第二人民医院 [34]河南省人民医院 [35]徐州医科大学附属医院 [36]南通市肿瘤医院 [37]浙江大学医学院附属邵逸夫医院(浙江省邵逸夫医院) [38]汕头市中心医院 [39]Instituto de Oncología de Rosario [40]CORI - Centro Oncológico Riojano Integral [41]Clinica Viedma [42]Coiba S.A. [43]Universidad de Buenos Aires - Facultad de Medicina - Fundacion CENIT [44]Fundacion Scherbovsky [45]Isis Clínica Especializada [46]Universidad de Buenos Aires - Facultad de Medicina - Fundacion CENIT [47]Clinica Adventista Belgrano [48]Hospital Alemán [49]Fundacion Scherbovsky [50]Hospital Británico de Buenos Aires [51]Hospital Privado - Centro Médico de Córdoba [52]Centro de Pesquisas Clínicas em Oncologia [53]Hospital Sao Rafael [54]Hospital Sírio-Libanês [55]Centro de Novos Tratamentos Itajaí [56]Instituto de Ensino e Pesquisa Clínica do Ceará [57]Universidade de Caxias do Sul [58]Instituto Brasileiro de Controle do Cancer (IBCC) [59]Hospital Moinhos de Vento [60]Associacoo de Combate ao Cancer em Goias - Hospital Araujo Jorge [61]Hospital de Cancer de Barretos - Fundacao Pio XII [62]Hospital de Caridade de Ijuí [63]Fundacao Faculdade Regional de Medicina de Sao José do Rio Preto [64]Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda [65]Hospital Sao Vicente de Paulo [66]Instituto do Cancer do Estado de Sao Paulo [67]Hospital Amaral Carvalho [68]Hospital Mae de Deus [69]Hospital Nossa Senhora da Conceicao (HNSC) [70]Oncologia Cirurgica e Cirurgia do Aparelho Digestivo [71]Liga Contra o Cancer [72]McGill University Health Centre [73]Centre Hospitalier de l'Université de Montréal (CHUM) [74]Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex [75]Centre hospitalier de l’Université Laval [76]Saskatoon Cancer Centre [77]Kingston General Hospital - Cancer Centre of Southeastern Ontario [78]The Credit Valley Hospital and Trillium Health Centre [79]CancerCare Manitoba [80]Sunnybrook Health Sciences Centre [81]Humber River Hospital [82]North York General Hospital [83]BC Cancer Agency Vancouver Centre [84]Jewish General Hospital [85]Sunnybrook Health Sciences Centre [86]Humber River Hospital [87]British Columbia Cancer Agency - Fraser Valley Centre [88]Hospitales Star Medica - Queretaro [89]Instituto Nacional de Cancerología-México [90]Centro de Investigacion Medica Aguascalientes [91]Centro Estatal De Cancerologia De Chihuahua [92]Grupo Médico Camino [93]Oaxaca Site Management Organization (OSMO) [94]Consultorio de Medicina Especializada Integra [95]Hospital Aranda de la Parra [96]Accelerium S de RL de C.V. [97]Christus Muguerza Hospital Vidriera [98]MENTRIALS SA de CV [99]Hospital Civil de Guadalajara - Antiguo Hospital Civil de Guadalajara [100]Centro Médico Dalinde [101]Universidad Autonoma de Nuevo Leon - Hospital Universitario [102]Centro Oncológico de Chihuahua [103]Centro Médico Monte Carmelo S.R.L. [104]Clínica Oncosalud [105]Clínica Anglo Americana [106]Aliada [107]Instituto Nacional de Enfermedades Neoplásicas [108]Hospital Nacional Daniel Alcides Carrión [109]Hospital Nacional Edgardo Rebagliati Martins [110]Rainier Hematology-Oncology [111]The Oncology Institute of Hope and Innovation - West Tucson [112]Research Medical Center [113]Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) [114]Florida Cancer Specialists & Research Institute - Colonial Office [115]The Oncology Institute of Hope and Innovation - Corona [116]Office of Emad Ibrahim,MD,INC [117]Northwell Health - Centers for Advanced Medicine [118]Northwest Georgia Oncology Centers,P.C. [119]Comprehensive Cancer Centers of Nevada - Henderson - Eastern Ave [120]Stephenson Cancer Center [121]University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion [122]The Oncology Institute of Hope and Innovation - Whittier [123]Memorial Sloan-Kettering Cancer Center [124]The Oncology Institute of Hope and Innovation - Thousand Oaks [125]Bon Secours Cancer Institute Medical Oncology - St. Francis [126]Tennessee Oncology - Chattanooga Oncology & Hematology Associates [127]Cone Health Cancer Center [128]Tufts Medical Center [129]University of Rochester [130]Washington University School of Medicine - Center for Advanced Medicine (CAM) [131]University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center [132]University of Maryland - Marlene and Stewart Greenebaum Cancer Center [133]San Juan Oncology Associates,P.C. [134]Mission Hope Cancer Center [135]Beth 以色列 Comprehensive Cancer Center- West Campus [136]Case Western Reserve University [137]QUEST Research Institute - Farmington Hills [138]Minnesota Oncology - Minneapolis Clinic [139]Banner MD Anderson Cancer Center [140]The Valley Hospital - The Robert and Audrey Luckow Pavilion [141]Arizona Clinical Research Center [142]University of California,San Francisco,Medical Center at Mount Zion [143]Levine Cancer Institute [144]Florida Hospital Cancer Institute [145]Texas Oncology - Baylor Charles A. Sammons Cancer Center [146]Mayo Clinic Hospital - Florida [147]Mayo Clinic Cancer Center (MCCC) - Rochester [148]University of New 墨西哥 Cancer Center [149]Waverly Hematology Oncology [150]Carle Cancer Center [151]Norton Cancer Institute [152]The Oncology Institute of Hope and Innovation - Corona [153]Quincy Medical Group [154]West Virginia University Hospitals,Inc. [155]Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute [156]Oregon Health & Science University (OHSU) - Knight Cancer Institute [157]John B. Amos Cancer Center [158]Carle Cancer Center [159]Ironwood Cancer & Research Centers [160]University Hospitals Seidman Cancer Center [161]New Hampshire Oncology-Hematology PA [162]University of Wisconsin-Madison - Carbone Cancer Center [163]Ballarat Base Hospital [164]Mater Hospital North Sydney [165]Orange Hospital [166]Ballarat Oncology & Heamatology Services [167]Icon Cancer Care - South Brisbane [168]Royal Adelaide Hospital [169]Ashford Cancer Centre Research [170]Calvary Mater Newcastle [171]Maroondah Hospital [172]Border Medical Oncology [173]Concord Repatriation General Hospital [174]Sunshine Coast University Private Hospital [175]Box Hill Hospital [176]Royal North Shore Hospital (RNSH) [177]Andrew Love Cancer Centre [178]Nepean Hospital [179]PASO Medical [180]Royal Brisbane and Women's Hospital [181]The Kinghorn Cancer Centre [182]Peter MacCallum Cancer Centre [183]Peninsula Health – Frankston Hospital [184]St John of God Murdoch Hospital [185]Saitama Cancer Center [186]The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR) [187]Aichi Cancer Center Hospital [188]National Hospital Organization Osaka National Hospital [189]Mie University Hospital [190]Osaka International Cancer Institute [191]Hiroshima City Hiroshima Citizens Hospital [192]Saitama Medical University International Medical Center [193]Sagara Hospital,Social Medical Corporation Hakuaikai [194]National Hospital Organization Hokkaido Cancer Center [195]National Hospital Organization Kyushu Cancer Center [196]Nagoya City University Hospital [197]Shizuoka Cancer Center [198]Kumamoto University Hospital [199]Kanagawa Cancer Center [200]Gunma Prefectural Cancer Center [201]National Hospital Organization Shikoku Cancer Center [202]Fukushima Medical University Hospital [203]National Cancer Center Hospital (NCCH) [204]Hokkaido University Hospital [205]St. Luke's International Hospital [206]Showa University Hospital [207]Kyoto University Hospital [208]Chiba Cancer Center [209]The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR) [210]Niigata Cancer Center Hospital [211]Kindai University Hospital [212]Sagara Hospital,Social Medical Corporation Hakuaikai [213]Toranomon Hospital [214]Samsung Medical Center [215]The Catholic University of Korea,St. Vincent's Hospital [216]Korea University Guro Hospital [217]Keimyung University Dongsan Hospital [218]National Cancer Center [219]Inha University Hospital [220]Pusan National University Hospital [221]Asan Medical Center [222]Severance Hospital - Yonsei Cancer Center [223]Seoul National University Bundang Hospital [224]Ajou University Hospital [225]Seoul National University Hospital [226]Cagayan de Oro Medical Center [227]University of Perpetual Help Medical Center (UPHDMC) [228]Manila Medical Services,Inc.- Manila Doctors Hospital [229]St. Luke's Medical Center [230]Southern Philippines Medical Center [231]Baguio General Hospital and Medical Center [232]Makati Medical Center [233]Cardinal Santos Medical Center [234]National Taiwan University Hospital [235]China Medical University Hospital [236]Chi Mei Hospital,Liouying [237]Chang Gung Medical Foundation - Linkou Branch [238]Taipei Veterans General Hospital [239]National Cheng Kung University Hospital [240]Koo Foundation Sun Yat-Sen Cancer Center [241]E-DA Cancer Hospital [242]Chi Mei Medical Center [243]Mackay Memorial Hospital-Taipei Branch [244]Tri-Service General Hospital-Neihu Main Facility [245]Ubonratchathani Cancer Hospital [246]Songklanagarind Hospital [247]King Chulalongkorn Memorial Hospital [248]Phramongkutklao Hospital [249]Ramathibodi Hospital [250]Srinagarind Hospital [251]Chiang Mai University (CMU) - Faculty of Medicine [252]Songklanagarind Hospital [253]Rajavithi Hospital [254]Clinique et Maternité Sainte-Elisabeth [255]Grand Hopital de Charleroi - Hopital Notre Dame [256]GZA Ziekenhuizen Campus Sint-Augustinus [257]Cliniques Universitaires Saint-Luc [258]Universitair Ziekenhuis Brussel [259]Antwerp University Hospital [260]Institut Jules Bordet [261]Fakultní nemocnice Královské Vinohrady [262]Thomayerova nemocnice [263]Nemocnice Chomutov [264]Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece [265]Nemocnice Na Bulovce [266]MEDICON a.s. - Poliklinika Zeleny Pruh - Onkocentrum Zeleny Pruh [267]Fakultní Nemocnice Olomouc [268]Fakultni Nemocnice v Motole (Motol University Hospital) - Onkologicka klinika 2. LF UK a FN Motol [269]Nemocnice Novy Jicín,A.S [270]Vseobecná fakultní nemocnice v Praze [271]Fakultní Nemocnice Ostrava [272]Institut Claudius Regaud [273]Centre Hospitalier Annecy Genevois [274]Centre Hospitalier Régional Metz-Thionville [275]Centre Paul Strauss [276]Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO) [277]Centre Hospitalier Lyon-Sud [278]Institut Régional du Cancer de Montpellier [279]CHRU Brest - Hopital Morvan [280]CHU Besancon - Hopital Jean Minjoz [281]Centre Henri Becquerel [282]Institut Sainte Catherine [283]Centre Catherine de Sienne [284]Klinikum der Universitat München [285]Universitatsklinikum Münster Zentralklinikum [286]Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg [287]Mammazentrum Hamburg - Krankenhaus Jerusalem Location [288]Hamatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus [289]Klinikum rechts der Isar der TU München [290]Universitatsklinikum Erlangen Frauenklinik [291]Medizinische Hochschule Hannover (MHH) [292]Kliniken Essen - Mitte [293]Agaplesion Markus Krankenhaus [294]Universitatsklinikum Carl Gustav Carus Dresden [295]Rotkreuzklinikum München Frauenklinik [296]Facharztzentrum Eppendorf [297]Universitatsklinikum Hamburg-Eppendorf (UKE) [298]St. Vincenz-Krankenhaus [299]Universitatsfrauenklinik - Magdeburg [300]Universitatsklinikum Jena [301]Universitatsklinikum Schleswig-Holstein [302]Klinikum Ernst von Bergmann gGmbH [303]Evangelische Kliniken Gelsenkirchen GmbH [304]Praxisklinik Krebsheilkunde fur Frauen/Brustzentrum [305]KMG Klinikum Sommerda [306]Medizinischen Fakultat Mannheim der Universitat Heidelberg [307]Johannes Wesling Klinikum Minden [308]Carl-Thiem-Klinikum Cottbus GmbH [309]Charite Research Organisation Gmbh [310]Universitats - Frauenklinik [311]Hamatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus [312]Johannes Wesling Klinikum Minden [313]Tolna Megyei Balassa Janos Korhaz [314]University of Debrecen [315]Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet [316]Magyar Honvédség Egészségügyi Kozpont Honvédkórház II [317]Országos Onkológiai Intézet [318]Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK)- Onkoterapias Intezet [319]Bács-Kiskun Megyei Kórház [320]Szent Margit Kórház [321]Jósa András Oktatókórház [322]Zala Megyei Szent Rafael Kórház [323]Jósa András Oktatókórház [324]Hadassah Ein Karem Hospital [325]Rambam Medical Center [326]Sheba Medical Center - Infectious Disease Unit [327]Meir Medical Center [328]Rabin Medical Center - Beilinson Hospital [329]Emek Medical Center [330]Shaare Zedek Medical Center [331]Soroka Medical Center [332]Hadassah Ein Karem Hospital [333]Tel Aviv Sourasky Medical Center [334]Azienda USL 6 Livorno [335]Fondazione IRCCS Istituto Nazionale dei Tumori [336]Nuovo Ospedale di Prato [337]Ospedale Policlinico San Martino [338]Institute for Cancer Research and Treatment (IRCC) [339]AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli [340]Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS [341]ASST Papa Giovanni XXIII [342]Azienda Ospedaliero - Universitaria di Modena Policlinico [343]Istituto Europeo di Oncologia [344]Policlinico Universitario Campus Bio-Medico [345]Ospedale Generale Provinciale Macerata [346]Arcispedale Santa Maria Nuova [347]Universitá degli Studi [348]Ospedale Policlinico San Martino [349]Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS [350]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy [351]Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW z W-MCO w Olsztynie [352]Szpital Uniwersytecki w Krakowie [353]Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy [354]Szpital Rejonowy im. dr. J. Rostka w Raciborzu [355]Instytut Centrum Zdrowia Matki Polki [356]Przychodnia Lekarska [357]Centrum Onkologii Ziemi Lubelskiej im.sw. Jana z Dukli [358]Dolnoslaskie Centrum Onkologii we Wroclawiu [359]Wielkopolskie Centrum Onkologii [360]Uniwersyteckie Centrum Kliniczne [361]Federal State Institution “Russian Cancer Research Center named after N. N. Blokhin” RAMS [362]Samara Regional Clinical Cancer Center [363]Moscow Clinical Scientific Center [364]Petrov Research Institute of Oncology [365]State Medical Institution Oncology Center # 2 [366]Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary [367]P. Herzen Moscow Oncology Research Institute [368]North-Western State Medical University named after I.I. Mechnikov [369]Republican Clinical Oncology Dispensary [370]Federal State Institution Medical Rehabilitation Centre of Roszdrav [371]Medical Center [372]Tomsk National Research Medical Center of the Russian Academy of Sciences [373]Tula Regional Clinical Hospital [374]Kaluga Regional Hospital [375]Regional Budget Institution of Health [376]State Budget Institution of Health Arkhangelsk Region “Arkhangelsk Clinical Oncology Dispensary” [377]Medical center [378]SBHI of Stavropol region [379]Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario [380]Fundación Instituto Valenciano de Oncología (IVO) [381]Hospital Universitario 12 de Octubre [382]Hospital del Mar [383]Hospital Universitario Vall d'Hebron [384]IOB Institute of Oncology - Hospital Quironsalud Barcelona [385]El Centro Oncológico de Galicia [386]Hospital Universitario Virgen del Rocío [387]Hospital Universitari Arnau de Vilanova de Lleida [388]Institut Catala d'Oncologia Hospitalet [389]Hospital Ruber Internacional [390]Hospital Universitario De Canarias [391]MD Anderson Cancer Center - Madrid [392]Complejo Hospitalario de Jaén [393]Hospital Quiron Valencia [394]Hospital Clínico San Carlos [395]Hospital Quiron Sagrado Corazon [396]Complejo Hospitalario de Navarra [397]Hospital General Universitario Gregorio Maranón [398]Hospital Universitario La Paz [399]Hospital Universitario Puerta de Hierro - Majadahonda [400]Hospital Universitari Sant Joan de Reus [401]Hospital Universitario Reina Sofía [402]Hospital Universitario Virgen de la Victoria [403]Hospital Clinico Universitario de Valencia [404]Hospital Universitario Virgen Macarena [405]Lewisham and Greenwich NHS Trust - Queen Elizabeth Hospital [406]North Middlesex University Hospital NHS Trust [407]The Christie NHS Foundation Trust [408]Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary [409]The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital [410]Betsi Cadwaladr University Health Board - Ysbyty Gwynedd [411]York Teaching Hospitals NHS Foundation Trust - The York Hospital [412]Derby Hospitals NHS Foundation Trust - Royal Derby Hospital [413]The Royal Free London NHS Foundation Trust - The Royal Free Hospital [414]The Royal Marsden [415]Gloucestershire Hospitals NHS Foundation Trust - Cheltenham General Hospital [416]University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre [417]Velindre Cancer Centre [418]NHS Grampian - Aberdeen Royal Infirmary [419]St. James's University Hospital [420]University Hospitals of Morecambe Bay NHS Foundation Trust - Royal Lancaster Infirmary [421]East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital [422]Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital [423]The Royal Marsden

研究目的:
主要目的:通过评估总体人群的 PFS,比较 Capivasertib + 氟维司群相对于安慰剂 + 氟维司群的作用。 次要目的:通过评估 PIK3CA/AKT/PTEN 改变亚组的 PFS,通过评估总体人群的 OS,PFS2,ORR,DoR,CBR,比较 Capivasertib + 氟维司群相对于安慰剂 + 氟维司群的作用。在总体人群和PIK3CA/AKT/PTEN 改变亚组中评估 Capivasertib + 氟维司群与安慰剂 + 氟维司群相比的安全性和耐受性;评估 Capivasertib + 氟维司群的 PK等。在总体人群中评估 Capivasertib + 氟维司群与安慰剂 + 氟维司群相比对患者疾病相关症状、功能和 HRQoL 的作用。通过评估总体人群中至 ECOG 体能状态较基线确定性恶化的时间来比较 Capivasertib + 氟维司群相对于安慰剂 + 氟维司群的作用。

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