Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
研究单位：[1]Sermonix Pharmaceuticals Inc.[2]Mayo Clinic - Phoenix,Phoenix,Arizona,United States,85054[3]University of Arizona - Cancer Center,Tucson,Arizona,United States,85719[4]California Research Institute,Los Angeles,California,United States,90027[5]Providence Medical Foundation - Santa Rosa, CA,Santa Rosa,California,United States,95403[6]Boca Raton Regional Hospital,Boca Raton,Florida,United States,33486[7]Mayo Clinic - Jacksonville,Jacksonville,Florida,United States,32224[8]Miami Cancer Institute,Miami,Florida,United States,33143[9]Miami Cancer Institute Plantation,Plantation,Florida,United States,33324[10]Emory University School of Medicine,Atlanta,Georgia,United States,30322[11]Norton Cancer Institute,Louisville,Kentucky,United States,40202[12]Johns Hopkins Kimmel Cancer Center,Baltimore,Maryland,United States,21231[13]Massachusetts General Hospital,Boston,Massachusetts,United States,02114[14]Dana-Farber Cancer Institute,Boston,Massachusetts,United States,02115[15]Beth Israel Deaconess Medical Center,Boston,Massachusetts,United States,02215[16]Cancer and Hematology Centers of Western Michigan,Grand Rapids,Michigan,United States,49503[17]Allina Health System DBA Virginia Piper Cancer Institute,Minneapolis,Minnesota,United States,55407[18]Mayo Clinic - Rochester,Rochester,Minnesota,United States,55905[19]Saint Luke''s Cancer Institute,Kansas City,Missouri,United States,64111[20]Washington University School of Medicine,Saint Louis,Missouri,United States,63110[21]Renown Regional Medical Centre,Reno,Nevada,United States,89502[22]New Jersey Cancer Care, PA,Belleville,New Jersey,United States,07109[23]Icahn School of Medicine at Mount Sinai,New York,New York,United States,10029[24]David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center,New York,New York,United States,10065[25]Duke University Medical Center,Durham,North Carolina,United States,27705[26]Altru Health Systems,Grand Forks,North Dakota,United States,58201[27]The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James),Columbus,Ohio,United States,42112[28]University of Pittsburgh Medical Center,Pittsburgh,Pennsylvania,United States,15232[29]Lyndon B. Johnson Hospital,Houston,Texas,United States,77026[30]Baylor College of Medicine,Houston,Texas,United States,77030[31]MD Anderson Cancer Center,Houston,Texas,United States,77030[32]Harris Health System - Smith Clinic,Houston,Texas,United States,77054[33]Blacktown Hospital,Blacktown,Australia[34]Concord Repatriation General Hospital,Concord,Australia[35]Mater Misericordiae Ltd, South Brisbane,South Brisbane,Australia[36]Cliniques Universitaires Saint-Luc,Brussels,Belgium[37]Antwerp University Hospital (UZA),Edegem,Belgium[38]Universitaire Ziekenhuizen Leuven,Leuven,Belgium[39]CHU UCL Namur - Site De Sainte-Elisabeth,Namur,Belgium[40]The Ottawa General Hospital,Ottawa,Ontario,Canada[41]Sunnybrook Health Sciences Centre -Bayview Campus,Toronto,Ontario,Canada[42]Hospital Maisonneuve-Rosemont,Montréal,Quebec,Canada[43]Lady Davis Institute for Medical Research Jewish General Hospital,Montréal,Quebec,Canada[44]CIUSSS du Saguenay-Lac-Saint-Jean,Saguenay,Quebec,Canada[45]Anhui Provincial Cancer Hospital,Anhui,China[46]Beijing Cancer Hospital,Beijing,China[47]The First Affiliated Hospital of Bengbu Medical University,Bengbu,China[48]The First Hospital of Jilin University,Changchun,China[49]The Second Xiangya Hospital of Central South University,Changsha,China[50]Sichuan Provincial People''s Hospital,Chengdu,China[51]West China Hospital, Sichuan University,Chengdu,China[52]The First Affiliated Hospital, Chongqing Medical University,Chongqi,China[53]The Second Hospital of Dalian Medical University,Dalian,China[54]Deyang People''s Hospital,Deyang,China[55]Fuyang Cancer Hosptial,Fuyang,China[56]Fujian Cancer Hospital,Fuzhou,China[57]Fujian Medical University Union Hospital,Fuzhou,China[58]Zhujiang Hospital of Nanfang Medical University,Guandong,China[59]Guangdong Provincial People''s Hospital,Guangdong,China[60]Meizhou People''s Hospital,Guangdong,China[61]Peking University Shenzhen Hospital,Guangdong,China[62]Sun Yat-Sen University- Cancer Center,Guangdong,China[63]Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University,Hangzhou,China[64]The First Affiliated Hospital, College of Medicine, Zhejiang University,Hangzhou,China[65]Zhejiang Provincial Hospital of Chinese Medicine,Hangzhou,China[66]Hebei Medical University - The Fourth Hospital - Hebei Provincial Tumor Hospital,Hebei,China[67]Xiangyang Central Hospital,Hubei,China[68]Xiangya Hospital Central South University,Hunan,China[69]Shandong Province Tumor Hospital,Jinan,China[70]Gansu Provincial Hospital,Lanzhou,China[71]The First Hospital of Lanzhou University,Lanzhou,China[72]Linyi Cancer Hospital,Linyi,China[73]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,China[74]The Affiliated Hospital of Southwest Medical University (Luzhou Medical College),Luzhou,China[75]Jiangxi Cancer Hospital,Nanchang,China[76]Nangchang People''s Hospital,Nanchang,China[77]Nanjing Drum Tower Hospital,Nanjing,China[78]Guangxi Medical University Cancer Hospital,Nanning,China[79]Nanyang Central Hospital,Nanyang,China[80]The Second People''s Hospital of Neijiang,Neijiang,China[81]Ningbo Medical Center Li Huili Hospital,Ningbo,China[82]Qingdao Central Hospital, University of Health and Rehabilitation Sciences,Qingdao,China[83]The Affiliated Hospital of Qingdao University,Qingdao,China[84]Fudan University Cancer Center,Shang''ai,China[85]First Affiliated Hospital of Xi''an Jiaotong University,Shanxi,China[86]The Central Hospital of Shaoyang,Shaoyang,China[87]Liaoning Cancer Hospital & Institute,Shenyang,China[88]Yuebei People''s Hospital,Shouguang,China[89]University of Electonic Science & Technology (UESTC) - Sichuan Cancer Hospital & Institute,Sichuan,China[90]Tianjin Cancer Hospital Airport Hospital,Tianjin,China[91]Tianjin Medical University Cancer Institute & Hospital,Tianjin,China[92]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China[93]Hubei Cancer Hospital,Wuhan,China[94]Union Hospital Tongji Medical College Huazhong University of Science and Technolog,Wuhan,China[95]The First Affiliated Hospital of Air Force Medical University,XI Ail,China[96]The first affiliated hospital of Xiamen University,Xiamen,China[97]Xuzhou Central Hospital,Xuzhou,China[98]Yuncheng Central Hospital,Yuncheng,China[99]Zhejiang cancer hospital,Zhejiang,China[100]Zhejiang Provincial People''s Hospital,Zhejiang,China[101]Henan Cancer Hospital,Zhengzhou,China[102]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China[103]Zhongshan City People''s Hospital,Zhongshan,China[104]Zhumadian Central Hospital,Zhumadian,China[105]The Affiliated Cancer Hospital of Xinjiang Medical University,Ürümqi,China[106]Service d''Oncologie Medicale - CHRU Besancon,Besançon,France[107]Institut Bergonie,Bordeaux,France[108]Centre Francois Baclesse,CAEN Cedex 05,France[109]Centre Oscar Lambret,Lille,France[110]Centre Leon Berard,Lyon,France[111]Institut Paoli-Calmettes,Marseille,France[112]CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC),Poitiers,France[113]Centre Henri Becquerel,Rouen,France[114]Institut Claudius Regaud,Toulouse,France[115]Universitaetsklinikum Carl Gustav Carus Dresden,Dresden,Germany[116]Klinikum rechts der Isar der Technischen Universitaet Muenchen,München,Germany[117]Rambam Health Care Campus,Haifa,Israel[118]Hadassah Ein-Karem Medical Center,Jerusalem,Israel[119]Shaare Zedek Medical Center,Jerusalem,Israel[120]Rabin MC,Petach Tikva,Israel[121]Kaplan Medical Center,Reẖovot,Israel[122]Tel Aviv Sourasky Medical Center,Tel Aviv,Israel[123]Sheba Medical Center,Tel HaShomer,Israel[124]Centro Riferimento Oncologico - Aviano,Aviano,Italy[125]IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.,Meldola,Italy[126]Istituto Europeo di Oncologia,Milano,Italy[127]Humanitas Istituto Clinico Catanese,Misterbianco,Italy[128]Azienda Ospedaliero-Universitaria di Modena,Modena,Italy[129]Istituto Nazionale Tumori IRCCS Fondazione G. Pascale,Napoli,Italy[130]Azienda Ospedaliero Universitaria di Parma,Parma,Italy[131]Fondazione IRCCS Policlinico San Matteo,Pavia,Italy[132]Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore,Roma,Italy[133]Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento,Verona,Italy[134]National Cancer Center,Gyeonggi-do,Korea, Republic of[135]Chonnam National University Hwasun Hospital,Hwasun,Korea, Republic of,58128[136]Asan Medical Center,Seoul,Korea, Republic of[137]Korea University Anam Hospital,Seoul,Korea, Republic of[138]Severance Hospital, Yonsei University Health System,Seoul,Korea, Republic of[139]KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej,Biała Podlaska,Poland[140]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, I Klinika Radioterapii i Chemioterapii,Gliwice,Poland[141]Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym,Krakow,Poland[142]SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej,Kraków,Poland[143]Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii,Poznań,Poland[144]Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center,Poznań,Poland[145]Mazowiecki Szpital Onkologiczny,Wieliszew,Poland[146]Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii,Łódź,Poland[147]Centrul Medical Focus,Bucharest,Romania[148]Filantropia Clinical Hospital,Bucharest,Romania[149]Radiotherapy Center Cluj,Cluj-Napoca,Romania[150]Onco Clinic Consult SA,Craiova,Romania[151]Oncology Center Sfantul Nectarie,Craiova,Romania[152]Gral Medical SRL,Piteşti,Romania[153]OncoMed Oncology Center,Timişoara,Romania[154]National Cancer Centre Singapore,Singapore,Singapore,168583[155]Curie Oncology,Singapore,Singapore,329563[156]Hospital Clinic Barcelona,Barcelona,Spain[157]Hospital Universitario Vall d''Hebron,Barcelona,Spain[158]Hospital Universitario Reina Sofia,Córdoba,Spain[159]Clinica Universidad de Navarra - Madrid,Madrid,Spain[160]Hospital Beata Maria Ana,Madrid,Spain[161]Hospital General Universitario Gregorio Maranon,Madrid,Spain[162]Hospital Universitario 12 de Octubre,Madrid,Spain[163]Hospital Universitario de La Princesa,Madrid,Spain[164]Hospital Regional Universitario de Malaga,Málaga,Spain[165]Clinica Universidad de Navarra - Pamplona,Pamplona,Spain[166]Instituto Valenciano de Oncologia,Valencia,Spain[167]Changhua Christian Hospital (CCH),Changhua,Taiwan[168]Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH),Kaohsiung,Taiwan[169]National Cheng Kung University Hospital,Tainan,Taiwan[170]Tri-Service General Hospital,Taipei City,Taiwan[171]Koo Foundation Sun Yat-Sen Cancer Center,Taipei,Taiwan[172]National Taiwan University Hospital,Taipei,Taiwan[173]Linkou Chang Gung Memorial Hospital (CGMHLK),Taoyuan City,Taiwan[174]Leeds Teaching Hospitals NHS Trust,Leeds,United Kingdom[175]Charing Cross Hospital,London,United Kingdom[176]The Christie NHS Foundation Trust,Manchester,United Kingdom[177]Nottingham City Hospital,Nottingham,United Kingdom
研究目的：
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.
