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ACTIVE NOT RECRUITING
NCT03725059
PHASE3

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

Official title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1240

Start Date

2018-12-27

Completion Date

2031-01-24

Last Updated

2025-07-11

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Pembrolizumab (K)

IV infusion Q3W

DRUG

Placebo (P)

Normal saline or dextrose IV infusion Q3W

DRUG

Paclitaxel (X)

IV infusion QW

DRUG

Doxorubicin (A)

IV infusion either in Q2W or Q3W

DRUG

Epirubicin (E)

IV infusion either in Q2W or Q3W

DRUG

Cyclophosphamide (C)

IV infusion either in Q2W or Q3W

DRUG

Endocrine therapy

Variable endocrine therapy for up 10 years

RADIATION

Radiation therapy

Variable radiation therapy per local standard of care

PROCEDURE

Surgery

Surgery for breast cancer

Locations (244)

Southern Cancer Center, PC ( Site 8003)

Daphne, Alabama, United States

Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)

Goodyear, Arizona, United States

Arizona Oncology Associates PC- HOPE ( Site 8008)

Tucson, Arizona, United States

Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)

Los Angeles, California, United States

El Camino Hospital Cancer Center ( Site 0004)

Mountain View, California, United States

Stanford Cancer Center ( Site 0072)

Palo Alto, California, United States

UC Davis Comprehensive Cancer Center ( Site 0073)

Sacramento, California, United States

University of Colorado, Anschutz Cancer Pavilion ( Site 0008)

Aurora, Colorado, United States

Baptist MD Anderson Cancer Center ( Site 0014)

Jacksonville, Florida, United States

Southeastern Regional Medical Center, Inc. ( Site 0075)

Newnan, Georgia, United States

The University of Chicago Medical Center ( Site 0080)

Chicago, Illinois, United States

Orchard Healthcare Research Inc. ( Site 0020)

Skokie, Illinois, United States

Midwestern Regional Medical Center, Inc. ( Site 0077)

Zion, Illinois, United States

Goshen Center for Cancer Care ( Site 0021)

Goshen, Indiana, United States

MercyOne Waterloo Cancer Center ( Site 0016)

Waterloo, Iowa, United States

James Graham Brown Cancer Center ( Site 0022)

Louisville, Kentucky, United States

Maryland Oncology Hematology, P.A. ( Site 8007)

Bethesda, Maryland, United States

Massachusetts General Hospital ( Site 0024)

Boston, Massachusetts, United States

MGH - North Shore Cancer Center ( Site 0081)

Danvers, Massachusetts, United States

MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)

Newton, Massachusetts, United States

Henry Ford Health System ( Site 0028)

Detroit, Michigan, United States

Mayo Clinic and Medical School (Rochester) ( Site 0029)

Rochester, Minnesota, United States

St. Vincent Frontier Cancer Center ( Site 0033)

Billings, Montana, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)

Omaha, Nebraska, United States

Holy Name Medical Center ( Site 0041)

Teaneck, New Jersey, United States

Weill Cornell Medical College ( Site 0043)

New York, New York, United States

CTCA Southwestern ( Site 0074)

Tulsa, Oklahoma, United States

OHSU Knight Cancer Institute ( Site 0051)

Portland, Oregon, United States

Northwest Cancer Specialists, P.C. ( Site 8000)

Tigard, Oregon, United States

Geisinger Medical Center ( Site 0052)

Danville, Pennsylvania, United States

Fox Chase Cancer Center ( Site 0078)

Philadelphia, Pennsylvania, United States

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)

Philadelphia, Pennsylvania, United States

Medical University of South Carolina ( Site 0053)

Charleston, South Carolina, United States

Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)

Nashville, Tennessee, United States

Texas Oncology-Austin Central ( Site 8004)

Austin, Texas, United States

Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)

Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)

Dallas, Texas, United States

Texas Oncology-Memorial City ( Site 8012)

Houston, Texas, United States

University of Texas-MD Anderson Cancer Center ( Site 0083)

Houston, Texas, United States

Texas Oncology- Plano East ( Site 8010)

Plano, Texas, United States

Texas Oncology - Northeast Texas ( Site 8006)

Tyler, Texas, United States

Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)

Midlothian, Virginia, United States

Virginia Oncology Associates ( Site 8001)

Norfolk, Virginia, United States

Kadlec Clinic Hematology and Oncology ( Site 0070)

Kennewick, Washington, United States

Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)

Spokane, Washington, United States

Chris OBrien Lifehouse ( Site 2107)

Camperdown, New South Wales, Australia

Royal North Shore Hospital ( Site 2100)

Sydney, New South Wales, Australia

Westmead Hospital ( Site 2101)

Sydney, New South Wales, Australia

Mater Misericordiae Ltd ( Site 2106)

South Brisbane, Queensland, Australia

Frankston Hospital ( Site 2103)

Frankston, Victoria, Australia

Peter MacCallum Cancer Centre ( Site 2102)

Melbourne, Victoria, Australia

Imelda Ziekenhuis Bonheiden ( Site 0703)

Bonheiden, Antwerpen, Belgium

UZ Antwerpen - Medical Oncology ( Site 0709)

Edegem, Antwerpen, Belgium

Institut Jules Bordet ( Site 0710)

Anderlecht, Bruxelles-Capitale, Region de, Belgium

Cliniques Universitaires Saint-Luc ( Site 0701)

Brussels, Bruxelles-Capitale, Region de, Belgium

CHC MontLegia ( Site 0707)

Liège, Liege, Belgium

Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)

Hasselt, Limburg, Belgium

CHU UCL Namur Site de Godinne ( Site 0706)

Yvoir, Namur, Belgium

AZ Maria Middelares Gent ( Site 0700)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0702)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge ( Site 0705)

Kortrijk, West-Vlaanderen, Belgium

Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)

Goiânia, Goiás, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

Ijuí, Rio Grande do Sul, Brazil

Associacao Hospitalar Moinhos de Vento ( Site 0201)

Porto Alegre, Rio Grande do Sul, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)

Porto Alegre, Rio Grande do Sul, Brazil

CEPON - Centro de Pesquisas Oncologicas ( Site 0208)

Florianópolis, Santa Catarina, Brazil

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)

Itajaí, Santa Catarina, Brazil

Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0200)

Rio de Janeiro, Brazil

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)

São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)

São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)

São Paulo, Brazil

Cross Cancer Institute ( Site 0115)

Edmonton, Alberta, Canada

BC Cancer-Vancouver Center ( Site 0116)

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre ( Site 0112)

Toronto, Ontario, Canada

CISSS de la Monteregie-Centre ( Site 0108)

Greenfield Park, Quebec, Canada

Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)

Montreal, Quebec, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0103)

Montreal, Quebec, Canada

CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)

Québec, Quebec, Canada

Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)

Trois-Rivières, Quebec, Canada

Anhui Provincial Hospital ( Site 3224)

Heifei, Anhui, China

Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)

Shanghai, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)

Fuzhou Fujian, Fujian, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)

Guangzhou, Guangdong, China

Fourth Hospital Of Hebei Medical University ( Site 3216)

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital ( Site 3200)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 3212)

Zhengzhou, Henan, China

Hubei Cancer Hospital ( Site 3211)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 3214)

Changsha, Hunan, China

The First Affiliated Hospital of Zhejiang University ( Site 3203)

Hangzhou, Jiangsu, China

The First Hospital of Jilin University ( Site 3201)

Changchun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 3205)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)

Xi’an, Shanxi, China

Tianjin Medical University Cancer Institute & Hospital ( Site 3209)

Tianjin, Tianjin Municipality, China

The Affiliated Cancer Hospital of Xinjiang Medical ( Site 3219)

Ürümqi, Xinjiang, China

Zhejiang Provincial People's Hospital ( Site 3225)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 3210)

Hangzhou, Zhejiang, China

Fundacion Colombiana de Cancerología Clinica Vida ( Site 0405)

Medellín, Antioquia, Colombia

Rodrigo Botero SAS ( Site 0407)

Medellín, Antioquia, Colombia

Clinica de la Costa S.A.S. ( Site 0400)

Barranquilla, Atlántico, Colombia

Centro de Investigacion Clinica del Country ( Site 0402)

Bogotá, Bogota D.C., Colombia

Fundacion Universitaria Sanitas ( Site 0403)

Bogotá, Bogota D.C., Colombia

IMAT S.A.S ( Site 0401)

Montería, Departamento de Córdoba, Colombia

Clínica Imbanaco S.A.S ( Site 0406)

Cali, Valle del Cauca Department, Colombia

Hospital Metropolitano - Sede Lindora ( Site 4203)

Santa Ana, Provincia de San José, Costa Rica

Centre Francois Baclesse ( Site 0927)

Caen, Calvados, France

Centre Georges Francois Leclerc ( Site 0920)

Dijon, Cote-d Or, France

Institut Claudius Regaud IUCT Oncopole ( Site 0903)

Toulouse, Haute-Garonne, France

Centre Oscar Lambret ( Site 0911)

Lille, Hauts-de-France, France

Institut Curie - Centre Rene Huguenin ( Site 0917)

Saint-Cloud, Hauts-de-Seine, France

Centre de Cancerologie du Grand Montpellier ( Site 0925)

Montpellier, Herault, France

CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)

Metz, Moselle, France

Institut Sainte Catherine ( Site 0916)

Avignon, Provence-Alpes-Côte d'Azur Region, France

Centre Jean Perrin ( Site 0909)

Clermont-Ferrand, Puy-de-Dome, France

Clinique Victor Hugo Le Mans ( Site 0906)

Le Mans, Sarthe, France

Institut Gustave Roussy ( Site 0926)

Villejuif, Val-de-Marne, France

Institut Curie ( Site 0900)

Paris, France

Hopital Saint-Louis ( Site 0908)

Paris, France

Hopital Tenon ( Site 0914)

Paris, France

Medizinische Management GmbH ( Site 1012)

Friedrichshafen, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen ( Site 1001)

Erlangen, Bavaria, Germany

Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)

Munich, Bavaria, Germany

Sana Klinikum Offenbach GmbH ( Site 1002)

Offenbach, Hesse, Germany

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)

Wiesbaden, Hesse, Germany

MVZ Onko Medical GmbH Hannover ( Site 1013)

Hanover, Lower Saxony, Germany

Gynaekologisches Zentrum ( Site 1003)

Bonn, North Rhine-Westphalia, Germany

Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)

Essen, North Rhine-Westphalia, Germany

Frauenklinik St. Louise ( Site 1014)

Paderborn, North Rhine-Westphalia, Germany

Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)

Saarbrücken, Saarland, Germany

Universitaetsklinikum Carl Gustav Carus ( Site 1008)

Dresden, Saxony, Germany

MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)

Nordhausen, Thuringia, Germany

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)

Pécs, Baranya, Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)

Miskolc, Borsod-Abauj Zemplen county, Hungary

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2913)

Kecskemét, Bács-Kiskun county, Hungary

Budapesti Szent Margit Korhaz ( Site 2901)

Budapest, Hungary

Orszagos Onkologiai Intezet ( Site 2908)

Budapest, Hungary

Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 2902)

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 2907)

Debrecen, Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)

Kaposvár, Hungary

Bon Secours Hospital ( Site 1554)

Cork, Ireland

St. James s Hospital ( Site 1553)

Dublin, Ireland

HaEmek Medical Center ( Site 1712)

Afula, Israel

Assuta Ashdod Public ( Site 1704)

Ashdod, Israel

Soroka Medical Center ( Site 1701)

Beersheba, Israel

Rambam Health Care Campus-Oncology Division ( Site 1705)

Haifa, Israel

Shaare Zedek Medical Center ( Site 1708)

Jerusalem, Israel

Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)

Jerusalem, Israel

Meir Medical Center ( Site 1710)

Kfar Saba, Israel

Holy Family Hospital ( Site 1711)

Nazareth, Israel

Rabin Medical Center ( Site 1702)

Petah Tikva, Israel

Chaim Sheba Medical Center. ( Site 1707)

Ramat Gan, Israel

Kaplan Medical Center ( Site 1703)

Rehovot, Israel

Sourasky Medical Center ( Site 1706)

Tel Aviv, Israel

Assuta Medical Center ( Site 1709)

Tel Aviv, Israel

Aichi Cancer Center ( Site 2601)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 2613)

Kashiwa, Chiba, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 2607)

Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital ( Site 2600)

Nishinomiya, Hyōgo, Japan

Kitasato University Hospital ( Site 2616)

Sagamihara, Kanagawa, Japan

Kumamoto University Hospital ( Site 2602)

Kumamoto, Kumamoto, Japan

Saitama Medical University International Medical Center ( Site 2606)

Hidaka, Saitama, Japan

Saitama Prefectural Cancer Center ( Site 2612)

Kitaadachi-gun, Saitama, Japan

Shizuoka Cancer Center ( Site 2611)

Suntogun, Shizuoka, Japan

Chiba Cancer Center ( Site 2605)

Chiba, Japan

Fukushima Medical University Hospital ( Site 2610)

Fukushima, Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 2603)

Hiroshima, Japan

National Hospital Organization Osaka National Hospital ( Site 2614)

Osaka, Japan

Toranomon Hospital ( Site 2608)

Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 2604)

Tokyo, Japan

Showa Medical University Hospital ( Site 2615)

Tokyo, Japan

Tauranga Hospital ( Site 2302)

Tauranga, Bay of Plenty, New Zealand

Canterbury Regional Cancer & Blood Services ( Site 2303)

Christchurch, Canterbury, New Zealand

Capital & Coast District Health Board - Wellington Hospital ( Site 2301)

Wellington, New Zealand

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Dolnoslaskie Centrum Onkologii. ( Site 1820)

Wroclaw, Lower Silesian Voivodeship, Poland

Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)

Ostrołęka, Masovian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1899)

Warsaw, Masovian Voivodeship, Poland

Mazowiecki Szpital Onkologiczny ( Site 1803)

Wieliszew, Masovian Voivodeship, Poland

Bialostockie Centrum Onkologii ( Site 1819)

Bialystok, Podlaskie Voivodeship, Poland

Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)

Gdansk, Pomeranian Voivodeship, Poland

Szpitale Pomorskie Sp. z o.o. ( Site 1818)

Gdynia, Pomeranian Voivodeship, Poland

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)

Bielsko-Biala, Silesian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)

Bytom, Silesian Voivodeship, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)

Gliwice, Silesian Voivodeship, Poland

Instytut Centrum Zdrowia Matki Polki ( Site 1821)

Lodz, Łódź Voivodeship, Poland

Fundacao Champalimaud ( Site 2500)

Lisboa, Aveiro District, Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2501)

Lisbon, Portugal

Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2503)

Porto, Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)

Porto, Portugal

UPR Comprehensive Cancer Center ( Site 6200)

San Juan, Puerto Rico

Arkhangelsk Clinical Oncological Dispensary ( Site 1901)

Arkhangelsk, Arkhangelskaya oblast, Russia

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)

Ufa, Baskortostan, Respublika, Russia

N.N. Blokhin NMRCO ( Site 1908)

Moscow, Moscow, Russia

Central Clinical Hospital with outpatient Clinic ( Site 1907)

Moscow, Moscow, Russia

Medical Rehabilitation Center ( Site 1912)

Moscow, Moscow, Russia

Ryazan Regional Clinical Oncology Dispensary ( Site 1910)

Ryazan, Ryazan Oblast, Russia

Railway Hospital of OJSC ( Site 1913)

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)

Saint Petersburg, Sankt-Peterburg, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1903)

Kazan', Tatarstan, Respublika, Russia

Tomsk Scientific Research Institute of Oncology ( Site 1905)

Tomsk, Tomsk Oblast, Russia

National Cancer Center ( Site 2204)

Goyang-si, Kyonggi-do, South Korea

Seoul National University Hospital ( Site 2200)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 2201)

Seoul, South Korea

Asan Medical Center ( Site 2202)

Seoul, South Korea

Samsung Medical Center ( Site 2203)

Seoul, South Korea

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Teresa Herrera - Chuac ( Site 1358)

A Coruña, La Coruna, Spain

Hospital Quiron de Madrid ( Site 1351)

Pozuelo de Alarcón, Madrid, Spain

Hospital General Universitario Gregorio Maranon ( Site 1367)

Madrid, Madrid, Comunidad de, Spain

Hospital Clinico Universitario de Valencia ( Site 1355)

Valencia, Valenciana, Comunitat, Spain

Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)

Barcelona, Spain

Hospital Vall D Hebron ( Site 1357)

Barcelona, Spain

Hospital Clinic I Provincial de Barcelona ( Site 1353)

Barcelona, Spain

Complejo Hospitalario de Jaen ( Site 1364)

Jaén, Spain

Hospital Beata María Ana-oncology ( Site 1370)

Madrid, Spain

Hospital Clinico San Carlos ( Site 1354)

Madrid, Spain

Hospital Universitario 12 de Octubre ( Site 1356)

Madrid, Spain

Hospital Universitario Virgen del Rocio ( Site 1360)

Seville, Spain

Hospital General Arnau de Vilanova de Valencia ( Site 1369)

Valencia, Spain

China Medical University Hospital ( Site 2401)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 2400)

Tainan, Taiwan

National Taiwan University Hospital ( Site 2404)

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital ( Site 2402)

Taoyuan District, Taiwan

MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 2702)

Dnipro, Dnipropetrovsk Oblast, Ukraine

MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 2707)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 2713)

Antonivka Village, Kherson Oblast, Ukraine

Khmelnitskiy Regional Onkology Dispensary ( Site 2704)

Khmelnitskiy, Khmelnytskyi Oblast, Ukraine

SNPE National Cancer Institute ( Site 2719)

Kyiv, Kyivska Oblast, Ukraine

MI Odesa Regional Clinical Hospital ( Site 2701)

Odesa, Odesa Oblast, Ukraine

MI Odessa Regional Oncological Centre ( Site 2714)

Odesa, Odesa Oblast, Ukraine

Medical center of the Limited Liability Company Yulis ( Site 2720)

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Kyiv City Clinical Oncology Centre ( Site 2716)

Kyiv, Ukraine

University Hospitals Bristol NHS Foundation Trust ( Site 1503)

Bristol, Bristol, City of, United Kingdom

Nottingham University Hospitals NHS Trust ( Site 1504)

Nottingham, England, United Kingdom

Colchester General Hospital ( Site 1508)

Colchester, Essex, United Kingdom

Barts Health NHS Trust ( Site 1500)

London, London, City of, United Kingdom

Guy's Hospital ( Site 1501)

London, London, City of, United Kingdom

St. Georges University Hospital NHS Foundation Trust ( Site 1505)

London, London, City of, United Kingdom

Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)

Solihull, United Kingdom

Royal Cornwall Hospital ( Site 1502)

Truro, United Kingdom