1,240
Participants
Start Date
December 27, 2018
Primary Completion Date
January 24, 2031
Study Completion Date
January 24, 2031
Pembrolizumab (K)
IV infusion Q3W
Placebo (P)
Normal saline or dextrose IV infusion Q3W
Paclitaxel (X)
IV infusion QW
Doxorubicin (A)
IV infusion either in Q2W or Q3W
Epirubicin (E)
IV infusion either in Q2W or Q3W
Cyclophosphamide (C)
IV infusion either in Q2W or Q3W
Endocrine therapy
Variable endocrine therapy for up 10 years
Radiation therapy
Variable radiation therapy per local standard of care
Surgery
Surgery for breast cancer
Linkou Chang Gung Memorial Hospital ( Site 2402), Taoyuan District
Budapesti Szent Margit Korhaz ( Site 2901), Budapest
Institut Jules Bordet ( Site 0710), Anderlecht
Orszagos Onkologiai Intezet ( Site 2908), Budapest
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 2902), Budapest
Cliniques Universitaires Saint-Luc ( Site 0701), Brussels
Chris OBrien Lifehouse ( Site 2107), Camperdown
Royal North Shore Hospital ( Site 2100), Sydney
Westmead Hospital ( Site 2101), Sydney
UZ Antwerpen - Medical Oncology ( Site 0709), Edegem
Imelda Ziekenhuis Bonheiden ( Site 0703), Bonheiden
Peter MacCallum Cancer Centre ( Site 2102), Melbourne
UZ Leuven ( Site 0702), Leuven
Tauranga Hospital ( Site 2302), Tauranga
Frankston Hospital ( Site 2103), Frankston
Jessa Ziekenhuis Campus Virga Jesse ( Site 0704), Hasselt
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904), Miskolc
CHC MontLegia ( Site 0707), Liège
Debreceni Egyetem Klinikai Kozpont ( Site 2907), Debrecen
Mater Misericordiae Ltd ( Site 2106), South Brisbane
CHU UCL Namur Site de Godinne ( Site 0706), Yvoir
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2913), Kecskemét
Capital & Coast District Health Board - Wellington Hospital ( Site 2301), Wellington
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915), Kaposvár
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905), Pécs
Canterbury Regional Cancer & Blood Services ( Site 2303), Christchurch
AZ Groeninge ( Site 0705), Kortrijk
AZ Maria Middelares Gent ( Site 0700), Ghent
Weill Cornell Medical College ( Site 0043), New York
National Cancer Center ( Site 2204), Goyang-si
Hospital Metropolitano - Sede Lindora ( Site 4203), Santa Ana
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403), Taipei
Centre Francois Baclesse ( Site 0927), Caen
Hospital Teresa Herrera - Chuac ( Site 1358), A Coruña
Geisinger Medical Center ( Site 0052), Danville
Fox Chase Cancer Center ( Site 0078), Philadelphia
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076), Philadelphia
Maryland Oncology Hematology, P.A. ( Site 8007), Bethesda
Centre Georges Francois Leclerc ( Site 0920), Dijon
Complejo Hospitalario de Jaen ( Site 1364), Jaén
Bon Secours St. Francis Medical Center Oncology Research ( Site 0064), Midlothian
Virginia Oncology Associates ( Site 8001), Norfolk
Hospital General Universitario Gregorio Maranon ( Site 1367), Madrid
Hospital Beata María Ana-oncology ( Site 1370), Madrid
Hospital Clinico San Carlos ( Site 1354), Madrid
Hospital Universitario 12 de Octubre ( Site 1356), Madrid
Hospital Quiron de Madrid ( Site 1351), Pozuelo de Alarcón
Khmelnitskiy Regional Onkology Dispensary ( Site 2704), Khmelnitskiy
Medical University of South Carolina ( Site 0053), Charleston
MVZ Onko Medical GmbH Hannover ( Site 1013), Hanover
Southeastern Regional Medical Center, Inc. ( Site 0075), Newnan
Institut Claudius Regaud IUCT Oncopole ( Site 0903), Toulouse
Baptist MD Anderson Cancer Center ( Site 0014), Jacksonville
Frauenklinik St. Louise ( Site 1014), Paderborn
Centre de Cancerologie du Grand Montpellier ( Site 0925), Montpellier
Southern Cancer Center, PC ( Site 8003), Daphne
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000), Nashville
James Graham Brown Cancer Center ( Site 0022), Louisville
China Medical University Hospital ( Site 2401), Taichung
Hospital Universitario Virgen del Rocio ( Site 1360), Seville
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006), Essen
Hospital Clinico Universitario de Valencia ( Site 1355), Valencia
Hospital General Arnau de Vilanova de Valencia ( Site 1369), Valencia
Goshen Center for Cancer Care ( Site 0021), Goshen
Henry Ford Health System ( Site 0028), Detroit
MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 2702), Dnipro
Rodrigo Botero SAS ( Site 0407), Medellín
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700), Kryviy Rih
MercyOne Waterloo Cancer Center ( Site 0016), Waterloo
Gynaekologisches Zentrum ( Site 1003), Bonn
Mayo Clinic and Medical School (Rochester) ( Site 0029), Rochester
CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919), Metz
Centre Oscar Lambret ( Site 0911), Lille
St. Vincent Frontier Cancer Center ( Site 0033), Billings
Orchard Healthcare Research Inc. ( Site 0020), Skokie
Midwestern Regional Medical Center, Inc. ( Site 0077), Zion
The University of Chicago Medical Center ( Site 0080), Chicago
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721), Kharkiv
Centre Jean Perrin ( Site 0909), Clermont-Ferrand
Sana Klinikum Offenbach GmbH ( Site 1002), Offenbach
MI Odesa Regional Clinical Hospital ( Site 2701), Odesa
MI Odessa Regional Oncological Centre ( Site 2714), Odesa
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004), Wiesbaden
Caritas Klinikum Saarbruecken St. Theresia ( Site 1009), Saarbrücken
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039), Omaha
Medical center of the Limited Liability Company Yulis ( Site 2720), Zaporizhzhia
National Cheng Kung University Hospital ( Site 2400), Tainan City
Clinique Victor Hugo Le Mans ( Site 0906), Le Mans
"Communal nonprofit enterprise Kherson Regional Oncology Dispensary of Kherson Regional Council ( Site 2713)", Antonivka Village
CTCA Southwestern ( Site 0074), Tulsa
Institut Curie ( Site 0900), Paris
Hopital Saint-Louis ( Site 0908), Paris
Hopital Tenon ( Site 0914), Paris
Texas Oncology- Plano East ( Site 8010), Plano
Texas Oncology-Dallas Presbyterian Hospital ( Site 8002), Dallas
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009), Dallas
Texas Oncology - Northeast Texas ( Site 8006), Tyler
MI Precarpathian Clinical Oncology Center ( Site 2707), Ivano-Frankivsk
Kaplan Medical Center ( Site 1703), Rehovot
Texas Oncology-Memorial City ( Site 8012), Houston
University of Texas-MD Anderson Cancer Center ( Site 0083), Houston
Texas Oncology-Austin Central ( Site 8004), Austin
University of Colorado, Anschutz Cancer Pavilion ( Site 0008), Aurora
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000), Munich
Institut Sainte Catherine ( Site 0916), Avignon
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001), Goodyear
Arizona Oncology Associates PC- HOPE ( Site 8008), Tucson
Medizinische Management GmbH ( Site 1012), Friedrichshafen
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079), Los Angeles
Universitaetsklinikum Erlangen ( Site 1001), Erlangen
Institut Curie - Centre Rene Huguenin ( Site 0917), Saint-Cloud
El Camino Hospital Cancer Center ( Site 0004), Mountain View
Stanford Cancer Center ( Site 0072), Palo Alto
Institut Gustave Roussy ( Site 0926), Villejuif
UC Davis Comprehensive Cancer Center ( Site 0073), Sacramento
Northwest Cancer Specialists, P.C. ( Site 8000), Tigard
OHSU Knight Cancer Institute ( Site 0051), Portland
Medical Oncology Associates (Summit Cancer Centers) ( Site 0066), Spokane
Kadlec Clinic Hematology and Oncology ( Site 0070), Kennewick
MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005), Nordhausen
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208), Beijing
National Taiwan University Hospital ( Site 2404), Taipei
Centro de Investigacion Clinica del Country ( Site 0402), Bogotá
Fundacion Universitaria Sanitas ( Site 0403), Bogotá
N.N. Blokhin NMRCO ( Site 1908), Moscow
Central Clinical Hospital with outpatient Clinic ( Site 1907), Moscow
Medical Rehabilitation Center ( Site 1912), Moscow
The First Hospital of Jilin University ( Site 3201), Changchun
Harbin Medical University Cancer Hospital ( Site 3200), Harbin
Arkhangelsk Clinical Oncological Dispensary ( Site 1901), Arkhangelsk
Railway Hospital of OJSC ( Site 1913), Saint Petersburg
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900), Saint Petersburg
Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215), Shanghai
Fudan University Shanghai Cancer Center ( Site 3205), Shanghai
Anhui Provincial Hospital ( Site 3224), Heifei
IMAT S.A.S ( Site 0401), Montería
Tianjin Medical University Cancer Institute & Hospital ( Site 3209), Tianjin
The First Affiliated Hospital of Zhejiang University ( Site 3203), Hangzhou
Zhejiang Provincial People's Hospital ( Site 3225), Hangzhou
Zhejiang Cancer Hospital ( Site 3210), Hangzhou
Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207), Fuzhou Fujian
Ryazan Regional Clinical Oncology Dispensary ( Site 1910), Ryazan
Hunan Cancer Hospital ( Site 3214), Changsha
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1903), Kazan'
Hubei Cancer Hospital ( Site 3211), Wuhan
Henan Cancer Hospital ( Site 3212), Zhengzhou
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909), Ufa
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213), Guangzhou
Tomsk Scientific Research Institute of Oncology ( Site 1905), Tomsk
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220), Xi’an
Clínica Imbanaco S.A.S ( Site 0406), Santiago de Cali
The Affiliated Cancer Hospital of Xinjiang Medical ( Site 3219), Ürümqi
Holy Family Hospital ( Site 1711), Nazareth
HaEmek Medical Center ( Site 1712), Afula
National Cancer Center Hospital East ( Site 2613), Kashiwa
Rambam Health Care Campus-Oncology Division ( Site 1705), Haifa
Meir Medical Center ( Site 1710), Kfar Saba
Chaim Sheba Medical Center. ( Site 1707), Ramat Gan
Sourasky Medical Center ( Site 1706), Tel Aviv
Assuta Medical Center ( Site 1709), Tel Aviv
Assuta Ashdod Public ( Site 1704), Ashdod
Soroka Medical Center ( Site 1701), Beersheba
Shaare Zedek Medical Center ( Site 1708), Jerusalem
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700), Jerusalem
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0200), Rio de Janeiro
Massachusetts General Hospital ( Site 0024), Boston
MGH - North Shore Cancer Center ( Site 0081), Danvers
MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082), Newton
Holy Name Medical Center ( Site 0041), Teaneck
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205), Goiânia
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206), Ijuí
Associacao Hospitalar Moinhos de Vento ( Site 0201), Porto Alegre
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202), Porto Alegre
CEPON - Centro de Pesquisas Oncologicas ( Site 0208), Florianópolis
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207), Itajaí
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204), São Paulo
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210), São Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209), São Paulo
Cross Cancer Institute ( Site 0115), Edmonton
BC Cancer-Vancouver Center ( Site 0116), Vancouver
Princess Margaret Cancer Centre ( Site 0112), Toronto
CISSS de la Monteregie-Centre ( Site 0108), Greenfield Park
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111), Montreal
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114), Montreal
Jewish General Hospital ( Site 0103), Montreal
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101), Québec
Centre Hospitalier Regional de Trois-Rivieres ( Site 0106), Trois-Rivières
Fourth Hospital Of Hebei Medical University ( Site 3216), Shijiazhuang
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0405), Medellín
Clinica de la Costa S.A.S. ( Site 0400), Barranquilla
Universitaetsklinikum Carl Gustav Carus ( Site 1008), Dresden
Bon Secours Hospital ( Site 1554), Cork
St. James s Hospital ( Site 1553), Dublin
Rabin Medical Center ( Site 1702), Petah Tikva
Aichi Cancer Center ( Site 2601), Nagoya
National Hospital Organization Hokkaido Cancer Center ( Site 2607), Sapporo
Hyogo Medical University Hospital ( Site 2600), Nishinomiya
Kitasato University Hospital ( Site 2616), Sagamihara
Kumamoto University Hospital ( Site 2602), Kumamoto
Saitama Medical University International Medical Center ( Site 2606), Hidaka
Saitama Prefectural Cancer Center ( Site 2612), Kitaadachi-gun
Shizuoka Cancer Center ( Site 2611), Suntogun
Chiba Cancer Center ( Site 2605), Chiba
Fukushima Medical University Hospital ( Site 2610), Fukushima
Hiroshima City Hiroshima Citizens Hospital ( Site 2603), Hiroshima
National Hospital Organization Osaka National Hospital ( Site 2614), Osaka
Toranomon Hospital ( Site 2608), Tokyo
Cancer Institute Hospital of JFCR ( Site 2604), Tokyo
Showa Medical University Hospital ( Site 2615), Tokyo
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800), Bydgoszcz
Dolnoslaskie Centrum Onkologii. ( Site 1820), Wroclaw
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814), Ostrołęka
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1899), Warsaw
Mazowiecki Szpital Onkologiczny ( Site 1803), Wieliszew
Bialostockie Centrum Onkologii ( Site 1819), Bialystok
Wojewodzkie Centrum Onkologii Copernicus ( Site 1817), Gdansk
Szpitale Pomorskie Sp. z o.o. ( Site 1818), Gdynia
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810), Bielsko-Biala
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807), Bytom
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801), Gliwice
Instytut Centrum Zdrowia Matki Polki ( Site 1821), Lodz
Fundacao Champalimaud ( Site 2500), Lisboa
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2501), Lisbon
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2503), Porto
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502), Porto
UPR Comprehensive Cancer Center ( Site 6200), San Juan
Seoul National University Hospital ( Site 2200), Seoul
Severance Hospital Yonsei University Health System ( Site 2201), Seoul
Asan Medical Center ( Site 2202), Seoul
Samsung Medical Center ( Site 2203), Seoul
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363), L'Hospitalet de Llobregat
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352), Barcelona
Hospital Vall D Hebron ( Site 1357), Barcelona
Hospital Clinic I Provincial de Barcelona ( Site 1353), Barcelona
SNPE National Cancer Institute ( Site 2719), Kyiv
Kyiv City Clinical Oncology Centre ( Site 2716), Kyiv
University Hospitals Bristol NHS Foundation Trust ( Site 1503), Bristol
Nottingham University Hospitals NHS Trust ( Site 1504), Nottingham
Colchester General Hospital ( Site 1508), Colchester
Barts Health NHS Trust ( Site 1500), London
Guy's Hospital ( Site 1501), London
St. Georges University Hospital NHS Foundation Trust ( Site 1505), London
Birmingham & Solihull Heartlands Hospital NHS ( Site 1506), Solihull
Royal Cornwall Hospital ( Site 1502), Truro
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INDUSTRY