A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
研究单位:[1]Merck Sharp & Dohme LLC[2]Ironwood Cancer & Research Centers ( Site 0036),Chandler 5289282,Arizona 5551752,United States,85224[3]Yale New Haven Hospital ( Site 0001),New Haven 4839366,Connecticut 4831725,United States,06510[4]AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007),Altamonte Springs 4145941,Florida 4155751,United States,32701[5]St. Luke''s Cancer Institute: Boise ( Site 0037),Boise 5586437,Idaho 5596512,United States,83712[6]MedStar Franklin Square Medical Center ( Site 0031),Baltimore 4347778,Maryland 4361885,United States,21237[7]MedStar Good Samaritan Hospital ( Site 0079),Baltimore 4347778,Maryland 4361885,United States,21239[8]MedStar Montgomery Medical Center ( Site 0078),Olney 4364537,Maryland 4361885,United States,20832[9]Holy Cross Hospital ( Site 0091),Silver Spring 4369596,Maryland 4361885,United States,20910[10]Allina Health Cancer Institute ( Site 0069),Minneapolis 5037649,Minnesota 5037779,United States,55407[11]Comprehensive Cancer Centers of Nevada ( Site 0015),Las Vegas 5506956,Nevada 5509151,United States,89119[12]Renown Regional Medical Center ( Site 0005),Reno 5511077,Nevada 5509151,United States,89502[13]New Mexico Oncology Hematology Consultants Ltd. ( Site 0019),Albuquerque 5454711,New Mexico 5481136,United States,87109[14]Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401),Mar del Plata 3430863,Buenos Aires 3435907,Argentina,B7600FZN[15]Instituto Alexander Fleming ( Site 2402),Mar del Plata 3430863,Buenos Aires 3435907,Argentina,C1426ANZ[16]Clinica Viedma ( Site 2403),Viedma 3832899,Río Negro Province 3838830,Argentina,R8500ACE[17]Fundacion Estudios Clinicos ( Site 2405),Rosario 3838583,Santa Fe Province 3836276,Argentina,S2000DEJ[18]Hospital Italiano de Cordoba ( Site 2406),Córdoba 3860259,Argentina,X5004BAL[19]ZAS Sint Augustinus ( Site 3102),Antwerp 2803138,Flanders 3337388,Belgium,2610[20]AZ Maria Middelares ( Site 3103),Ghent 2797656,Oost-Vlaanderen,Belgium,9000[21]Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301),São Jose Do Rio Preto,São Paulo 3448433,Brazil,15090-000[22]Jewish General Hospital ( Site 0203),Montreal 6077243,Quebec 6115047,Canada,H3T 1E2[23]St. Marys Hospital Center ( Site 0201),Montreal 6077243,Quebec 6115047,Canada,H3T 1M5[24]Hopital Du Saint-Sacrement ( Site 0210),Québec 6325494,Quebec 6115047,Canada,G1S 4L8[25]IC La Serena Research ( Site 2007),La Serena 3884373,Coquimbo Region 3893623,Chile,1720430[26]FALP ( Site 2000),Santiago 3871336,Region M. de Santiago,Chile,7500921[27]Clínica UC San Carlos de Apoquindo ( Site 2008),Santiago 3871336,Region M. de Santiago,Chile,7620002[28]Bradfordhill ( Site 2001),Santiago 3871336,Region M. de Santiago,Chile,8420383[29]ONCOCENTRO APYS ( Site 2005),Viña del Mar 3868121,Región de Valparaíso 3868621,Chile,2520598[30]Biocenter ( Site 2009),Concepción 3893894,Región del Biobío 3898380,Chile,4070196[31]The First Afflilated Hospital of Bengbu Medical College ( Site 5022),Bengbu 1816440,Anhui 1818058,China,233004[32]The First Affiliated Hospital of Chongqing Medical University ( Site 5039),Chongqing 1814906,Chongqing Municipality 1814905,China,400016[33]Chongqing University Three Gorges Hospital ( Site 5020),Chongqing 1814906,Chongqing Municipality 1814905,China,404000[34]Sun Yat-Sen University Cancer Center ( Site 5014),Guangzhou 1809858,Guangdong 1809935,China,510060[35]Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008),Nanning 1799869,Guangxi 1809867,China,530201[36]Jiangsu Province Hospital ( Site 5009),Nanjing 1799962,Jiangsu 1806260,China,210029[37]Xuzhou Central Hospital ( Site 5036),Xuzhou 10630003,Jiangsu 1806260,China,221009[38]The First Hospital of Jilin University ( Site 5003),Changchun 2038180,Jilin 2036500,China,130021[39]Jinan Central Hospital ( Site 5031),Jinan 1805753,Shandong 1796328,China,250013[40]LinYi Cancer Hospital ( Site 5021),Linyi 1803318,Shandong 1796328,China,276000[41]Sichuan Cancer Hospital. ( Site 5018),Chengdu 1815286,Sichuan 1794299,China,610041[42]Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006),Ürümqi 1529102,Xinjiang 1529047,China,830011[43]Zhejiang Cancer Hospital ( Site 5012),Hangzhou 1808926,Zhejiang 1784764,China,310022[44]The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024),Hangzhou 1808926,Zhejiang 1784764,China,310052[45]Taizhou Hospital of Zhejiang Province ( Site 5029),Linhai 1803422,Zhejiang 1784764,China,317000[46]Instituto de Cancerología ( Site 2206),Medellín 3674962,Antioquia 3689815,Colombia,50034[47]Centro Cancerologico del Caribe LTD ( Site 2209),Barranquilla 3689147,Atlántico 3689436,Colombia,080001[48]FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203),Bogotá 3688689,Bogota D.C. 3688685,Colombia,110131[49]Rambam Health Care Campus ( Site 3700),Haifa 294801,Israel,3109601[50]Shaare Zedek Medical Center ( Site 3704),Jerusalem 281184,Israel,9103102[51]Rabin Medical Center ( Site 3702),Petah Tikva 293918,Israel,4941492[52]Sheba Medical Center ( Site 3701),Ramat Gan 293788,Israel,5265601[53]Sourasky Medical Center ( Site 3703),Tel Aviv 293397,Israel,6423906[54]Nagoya City University Hospital ( Site 5108),Nagoya 1856057,Aichi-ken 1865694,Japan,467-8602[55]Hokkaido University Hospital ( Site 5100),Sapporo 2128295,Hokkaido 2130037,Japan,060-8648[56]Tokai University Hospital ( Site 5107),Isehara 1861449,Kanagawa 1860291,Japan,259-1193[57]Mie University Hospital ( Site 5109),Tsu 1849796,Mie-ken 1857352,Japan,514-8507[58]The University of Osaka Hospital ( Site 5111),Suita 1851483,Osaka 1853904,Japan,565-0871[59]Saitama Medical University International Medical Center ( Site 5116),Hidaka 6822161,Saitama 1853226,Japan,350-1298[60]Showa Medical University Hospital ( Site 5103),Shinagawa,Tokyo 1850144,Japan,142-8666[61]Fukushima Medical University Hospital ( Site 5101),Fukushima 2112923,Japan,960-1295[62]Hiroshima City Hiroshima Citizens Hospital ( Site 5113),Hiroshima 1862415,Japan,730-8518[63]Social medical corporation Hakuaikai Sagara Hospital ( Site 5114),Kagoshima 1860827,Japan,892-0833[64]Harbour Cancer & Wellness ( Site 5600),Newmarket 6232400,Auckland 2193734,New Zealand,1023[65]Pratia MCM Krakow ( Site 3812),Krakow 3094802,Lesser Poland Voivodeship 858786,Poland,30-727[66]Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3801),Siedlce 759412,Masovian Voivodeship 858787,Poland,08-110[67]Mazowiecki Szpital Onkologiczny ( Site 3807),Wieliszew 755886,Masovian Voivodeship 858787,Poland,05-135[68]Szpitale Pomorskie Sp. z o. o. ( Site 3805),Gdynia 3099424,Pomeranian Voivodeship 3337496,Poland,81-519[69]Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 3800),Koszalin 3095049,West Pomeranian Voivodeship 3337499,Poland,75-581[70]Institutul Oncologic Cluj ( Site 4701),Cluj-Napoca 681290,Cluj 681291,Romania,400015[71]S.C. Radiotherapy Center Cluj S.R.L ( Site 4705),Comuna Floresti,Cluj 681291,Romania,407280[72]"Centrul de Oncologie ""Sfântul Nectarie"" ( Site 4702),Craiova 680332,Dolj 679134,Romania,200542"[73]Centrul Medical Neolife- Baneasa ( Site 4706),Bucharest 683506,Romania,077190[74]National Cancer Center ( Site 5202),Goyang-si 1842485,Kyonggi-do,South Korea,10408[75]Seoul National University Bundang Hospital ( Site 5204),Seongnam 6876792,Kyonggi-do,South Korea,13620[76]Kyungpook National University Chilgok Hospital ( Site 5205),Daegu 1835329,Kyongsangbuk-do,South Korea,41404[77]Seoul National University Hospital ( Site 5200),Seoul 1835848,South Korea,03080[78]Severance Hospital Yonsei University Health System ( Site 5201),Seoul 1835848,South Korea,03722[79]Samsung Medical Center ( Site 5203),Seoul 1835848,South Korea,06351[80]Hospital Clinico San Carlos ( Site 4100),Madrid 3117735,Madrid, Comunidad de,Spain,28040[81]Hospital General Universitario de Valencia ( Site 4102),Valencia 2509954,Valenciana, Comunitat,Spain,46014[82]Parc de Salut Mar - Hospital del Mar ( Site 4106),Barcelona 3128760,Spain,08003[83]Hospital Beata María Ana ( Site 4105),Madrid 3117735,Spain,28007[84]Hospital Universitario Ramon y Cajal ( Site 4103),Madrid 3117735,Spain,28034[85]Taichung Veterans General Hospital ( Site 5303),Taichung 1668399,Taiwan,407[86]National Cheng Kung University Hospital ( Site 5304),Tainan City 1668355,Taiwan,70403[87]National Taiwan University Hospital ( Site 5300),Taipei 1668341,Taiwan,100225[88]Mackay Memorial Hospital ( Site 5301),Taipei 1668341,Taiwan,104[89]Chang Gung Memorial Hospital ( Site 5302),Taoyuan District 1667905,Taiwan,333[90]Faculty of Medicine Siriraj Hospital ( Site 5800),Bangkok 1609350,Bangkok 1609348,Thailand,10700[91]Songklanagarind hospital ( Site 5801),Hat Yai 1610780,Changwat Songkhla 1606146,Thailand,90110[92]Faculty of Medicine - Khon Kaen University ( Site 5802),Khon Kaen 1609776,Thailand,40002[93]Royal Cornwall Hospital ( Site 4003),Truro 2635412,Cornwall,United Kingdom,TR13LJ[94]St Bartholomew''s Hospital ( Site 4001),London 2643743,London, City of,United Kingdom,EC1A7BE[95]Nottingham University Hospital NHS Trust ( Site 4009),Nottingham 2641170,Nottinghamshire,United Kingdom,NG51PB
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.