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NCT06393374PHASE3Recruiting

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Merck Sharp & Dohme LLC

Start Date

6/24/2024

Completion Date

12/14/2037

Summary

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC * Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery * Has non-pathologic complete response at surgery * Is able to continue on adjuvant pembrolizumab * Randomization must be conducted within 16 weeks from surgical resection * Completed adjuvant radiation therapy (if indicated) and recovered before randomization * Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception * For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available * Has Grade \>2 peripheral neuropathy * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC * Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks * Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active hepatitis B and hepatitis C virus infection * Has history of allogeneic tissue/solid organ transplant

Interventions

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Sacituzumab tirumotecan

DRUG

Capecitabine

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Conditions

Triple-Negative Breast Cancer

Locations

Infirmary Cancer Care ( Site 0001)

Mobile, Alabama 36607

United States

Ironwood Cancer & Research Centers-Research ( Site 0054)

Chandler, Arizona 85224

United States

MemorialCare Orange Coast Medical Center ( Site 9501)

Fountain Valley, California 92708

United States

Scripps Cancer Center ( Site 0052)

La Jolla, California 92037

United States

Cancer and Blood Specialty Clinic ( Site 0008)

Los Alamitos, California 90720

United States

Kaiser Permanente - Oakland ( Site 0079)

Oakland, California 94611

United States

Profound Research LLC ( Site 0105)

Oceanside, California 92056

United States

Kaiser Permanente - Roseville ( Site 0081)

Roseville, California 95661

United States

Kaiser Permanente - San Francisco ( Site 0080)

San Francisco, California 94115

United States

Kaiser Permanente - Santa Clara ( Site 0082)

Santa Clara, California 95051

United States

Providence Medical Foundation ( Site 9543)

Santa Rosa, California 95403

United States

Kaiser Permanente Vallejo Medical Center ( Site 0060)

Vallejo, California 94589

United States

Kaiser Permanente - Walnut Creek ( Site 0078)

Walnut Creek, California 94596

United States

Bass Medical Group ( Site 0089)

Walnut Creek, California 94598

United States

Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)

Grand Junction, Colorado 81501

United States

Yale Cancer Center ( Site 0053)

New Haven, Connecticut 06510

United States

AdventHealth Altamonte Springs ( Site 0125)

Altamonte Springs, Florida 32701

United States

Orlando Health Cancer Institute ( Site 0030)

Orlando, Florida 32806

United States

Comprehensive Hematology Oncology ( Site 0091)

St. Petersburg, Florida 33709

United States

Cleveland Clinic Martin North Hospital ( Site 0114)

Stuart, Florida 34994

United States

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)

Thomasville, Georgia 31792

United States

Illinois Cancer Specialists (ICS) ( Site 8010)

Arlington Heights, Illinois 60005

United States

Orchard Healthcare Research Inc. ( Site 0014)

Skokie, Illinois 60077

United States

Northwest Cancer Center - Dyer Clinic ( Site 0097)

Dyer, Indiana 46311

United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0011)

Fort Wayne, Indiana 46845

United States

Cancer Center of Kansas ( Site 0004)

Wichita, Kansas 67214

United States

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)

Edgewood, Kentucky 41017

United States

CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)

Alexandria, Louisiana 71301

United States

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)

Monroe, Louisiana 71202

United States

Louisiana State University Health Sciences Shreveport ( Site 0029)

Shreveport, Louisiana 71103

United States

Holy Cross Hospital ( Site 0069)

Silver Spring, Maryland 20910

United States

University of Michigan ( Site 0103)

Ann Arbor, Michigan 48109

United States

Profound Research LLC ( Site 0074)

Royal Oak, Michigan 48073

United States

Metro-Minnesota Community Clinical Oncology ( Site 0031)

Saint Louis Park, Minnesota 55426

United States

University of Mississippi Medical Center ( Site 0043)

Jackson, Mississippi 39216

United States

SSM Health Cancer Care - Fenton ( Site 0088)

Fenton, Missouri 63026

United States

Lake Regional Hospital ( Site 0009)

Osage Beach, Missouri 65065

United States

Siteman Cancer Center ( Site 0099)

St Louis, Missouri 63108

United States

Optum Care Cancer Center ( Site 9535)

Las Vegas, Nevada 89102

United States

Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)

Las Vegas, Nevada 89128

United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)

Albuquerque, New Mexico 87109

United States

CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)

Santa Fe, New Mexico 87505

United States

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)

New York, New York 10011

United States

Icahn School of Medicine at Mount Sinai ( Site 0123)

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center ( Site 0067)

New York, New York 10065

United States

Clinical Research Alliance ( Site 0086)

Westbury, New York 11590

United States

Levine Cancer Institute ( Site 0083)

Charlotte, North Carolina 28204

United States

Cape Fear Valley Health System ( Site 0136)

Fayetteville, North Carolina 28304

United States

Sanford Cancer Center Bismarck ( Site 0058)

Bismarck, North Dakota 58501

United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)

Fargo, North Dakota 58102

United States

Altru Cancer Center ( Site 0104)

Grand Forks, North Dakota 58201

United States

Cleveland Clinic - Mercy Hospital ( Site 0057)

Canton, Ohio 44708

United States

Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)

Massillon, Ohio 44646

United States

Taylor Cancer Research Center ( Site 9500)

Maumee, Ohio 43537

United States

Genesis Healthcare System ( Site 0025)

Zanesville, Ohio 43701

United States

Hightower Clinical, LLC ( Site 0085)

Oklahoma City, Oklahoma 73102

United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)

Tulsa, Oklahoma 74146

United States

Providence Portland Medical Center ( Site 0116)

Portland, Oregon 97213

United States

Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)

Portland, Oregon 97225

United States

Sidney Kimmel Cancer Center at Jefferson ( Site 0049)

Philadelphia, Pennsylvania 19107

United States

Cancer Care Associates Of York ( Site 9517)

York, Pennsylvania 17403

United States

Sanford Cancer Center ( Site 0059)

Sioux Falls, South Dakota 57104

United States

West Cancer Center and Research Institute ( Site 0084)

Germantown, Tennessee 38138

United States

Baptist Cancer Center ( Site 0101)

Memphis, Tennessee 38120

United States

One Oncology - Tennessee Oncology ( Site 0098)

Nashville, Tennessee 37203

United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee 37203

United States

Tennessee Oncology ( Site 0111)

Nashville, Tennessee 37203

United States

Nashville General Hospital ( Site 0072)

Nashville, Tennessee 37208

United States

Vanderbilt Health One Hundred Oaks ( Site 0042)

Nashville, Tennessee 37212

United States

Hendrick Medical Center ( Site 0117)

Abilene, Texas 79601

United States

Harrington Cancer Center ( Site 0061)

Amarillo, Texas 79106

United States

Texas Oncology - DFW ( Site 8000)

Dallas, Texas 75246

United States

Parkland Health & Hospital System ( Site 0096)

Dallas, Texas 75390

United States

University of Texas Southwestern Medical Center ( Site 0032)

Dallas, Texas 75390

United States

Texas Oncology - Northeast Texas ( Site 8005)

Flower Mound, Texas 75028

United States

John Peter Smith Hospital ( Site 0106)

Fort Worth, Texas 76104

United States

Oncology Consultants P.A. ( Site 0107)

Houston, Texas 77030

United States

Laguna Clinical Research Associates LLC ( Site 0068)

Laredo, Texas 78041

United States

Mays Cancer Center ( Site 0122)

San Antonio, Texas 78229

United States

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)

Tyler, Texas 75701

United States

Texas Oncology - Gulf Coast ( Site 8009)

Webster, Texas 77598

United States

Intermountain Medical Center ( Site 0113)

Murray, Utah 84107

United States

Mary Washington Hospital ( Site 0129)

Fredericksburg, Virginia 22405

United States

Hematology Oncology Associates of Fredericksburg ( Site 9550)

Fredericksburg, Virginia 22408

United States

Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)

Midlothian, Virginia 23114

United States

Virginia Oncology Associates (VOA) ( Site 8008)

Norfolk, Virginia 23502

United States

Virginia Cancer Institute ( Site 0034)

Richmond, Virginia 23229

United States

Northwest Medical Specialties, PLLC ( Site 0093)

Tacoma, Washington 98405

United States

SSM Health Dean Medical Group ( Site 0087)

Madison, Wisconsin 53715

United States

Hospital Aleman-Oncology ( Site 0501)

Capital Federal, Buenos Aires C1118AAT

Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0502)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1280AEB

Argentina

Instituto de Oncología Angel H. Roffo ( Site 0503)

Buenos Aires, Buenos Aires F.D. C1417

Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 0509)

Buenos Aires, Buenos Aires F.D. C1426ANZ

Argentina

Sanatorio Parque ( Site 0512)

Rosario, Santa Fe Province S2000DSV

Argentina

Sanatorio Finochietto ( Site 0513)

Buenos Aires, C1187AAN

Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)

Buenos Aires, C1431FWO

Argentina

Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)

Macquarie University, New South Wales 2109

Australia

Westmead Hospital ( Site 2700)

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)

Brisbane, Queensland 4029

Australia

Frankston Hospital-Oncology and Haematology ( Site 2704)

Frankston, Victoria 3199

Australia

Medizinische Universitaet Innsbruck ( Site 1200)

Innsbruck, Tyrol 6020

Austria

Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)

Linz, Upper Austria 4020

Austria

Klinikum Wels-Grieskirchen ( Site 1205)

Wels, Upper Austria 4600

Austria

Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)

Salzburg, 5020

Austria

Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)

Vienna, 1090

Austria

Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)

Brussels, Bruxelles-Capitale, Region de 1200

Belgium

AZ Maria Middelares-IKG ( Site 0903)

Ghent, Oost-Vlaanderen 9000

Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)

Namur, 5530

Belgium

PRONUTRIR-CLINICAL RESEARCH ( Site 0609)

Fortaleza, Ceará 60810-180

Brazil

Hospital Santa Rita de Cassia ( Site 0617)

Vitória, Espírito Santo 29043-260

Brazil

Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)

Teresina, Piauí 64049-200

Brazil

Hospital do Câncer Mãe de Deus ( Site 0604)

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Instituto de Oncologia Saint Gallen ( Site 0614)

Santa Cruz do Sul, Rio Grande do Sul 96830-180

Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0616)

Lages, Santa Catarina 88501-001

Brazil

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)

Taubaté, São Paulo 12030-200

Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)

São Paulo, 04014-002

Brazil

Cross Cancer Institute ( Site 0407)

Edmonton, Alberta T6G 1Z2

Canada

BC Cancer Vancouver ( Site 0404)

Vancouver, British Columbia V5Z 4E6

Canada

CancerCare Manitoba ( Site 0411)

Winnipeg, Manitoba R2H 2A6

Canada

The Moncton Hospital ( Site 0401)

Moncton, New Brunswick E1C 6Z8

Canada

QEII Health Sciences Centre - Victoria General Site ( Site 0418)

Halifax, Nova Scotia B3H 2Y9

Canada

Southlake Health ( Site 0413)

Newmarket, Ontario L3Y 2P9

Canada

The Ottawa Hospital - General Campus ( Site 0414)

Ottawa, Ontario K1H 8L6

Canada

North York General Hospital ( Site 0415)

Toronto, Ontario M2K 1E1

Canada

Princess Margaret Cancer Centre ( Site 0400)

Toronto, Ontario M5G 2M9

Canada

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)

Greenfield Park, Quebec J4V 2H1

Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)

Montreal, Quebec H1T 2M4

Canada

Centre Hospitalier de l'Université de Montréal ( Site 0403)

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital ( Site 0416)

Montreal, Quebec H3T 1E2

Canada

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)

Rimouski, Quebec G5L 5T1

Canada

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)

Trois-Rivières, Quebec G8Z 3R9

Canada

Clinica Somer ( Site 3704)

Rionegro, Antioquia 054040

Colombia

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)

Bogotá, Bogota D.C. 110131

Colombia

Instituto Nacional De Cancerologia ( Site 3701)

Bogotá, Bogota D.C. 111511

Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)

Valledupar, Cesar Department 200001

Colombia

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)

Brno, Brno-mesto 656 53

Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)

Olomouc, Olomouc Region 779 00

Czechia

Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)

Prague, Praha 2 128 08

Czechia

Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)

Prague, Praha 4 14059

Czechia

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)

Prague, Praha 5 150 06

Czechia

Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)

České Budějovice, South Bohemian Region 37001

Czechia

Herlev og Gentofte Hospital. ( Site 3203)

Herlev, Capital Region 2730

Denmark

Aarhus Universitets hospital ( Site 3202)

Aarhus N, Central Jutland 8200

Denmark

Aalborg Universitetshospital, Syd ( Site 3206)

Aalborg, North Denmark 9000

Denmark

Odense Universitetshospital ( Site 3201)

Odense C, Region Syddanmark 5000

Denmark

Sygehus Soenderjylland ( Site 3204)

Sønderborg, Region Syddanmark 6400

Denmark

Vejle Sygehus. ( Site 3205)

Vejle, Region Syddanmark 7100

Denmark

Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 1101)

Kuopio, Northern Savonia 70210

Finland

Tampereen yliopistollinen sairaala ( Site 1102)

Tampere, Pirkanmaa 33520

Finland

Turku University Hospital-Department of Oncology ( Site 1103)

Turku, Southwest Finland 20520

Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)

Helsinki, Uusimaa 00029

Finland

Centre Antoine-Lacassagne ( Site 1308)

Nice, Alpes-Maritimes 06189

France

Centre Hospitalier de la Cote Basque ( Site 1315)

Bayonne, Aquitaine 64109

France

CENTRE LEON BERARD ( Site 1300)

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)

Clermont-Ferrand, Auvergne 63011

France

Institut Paoli-Calmettes ( Site 1309)

Marseille, Bouches-du-Rhone 13009

France

Centre François Baclesse ( Site 1318)

Caen, Calvados 14076

France

Centre Georges François Leclerc ( Site 1312)

Dijon, Cote-d Or 21079

France

CHU Besançon ( Site 1311)

Besançon, Doubs 25000

France

Hôpital Privé Drôme-Ardèche ( Site 1301)

Valence, Drome 26000

France

CHRU Brest - Hopital Cavale Blanche ( Site 1304)

Brest, Finistere 29200

France

Clinique Tivoli Ducos ( Site 1322)

Bordeaux, Gironde 33000

France

Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)

Levallois-Perret, Hauts-de-Seine 92300

France

Institut de Cancérologie de l'Ouest ( Site 1305)

Saint-Herblain, Loire-Atlantique 44805

France

Institut de Cancérologie de l'Ouest ( Site 1316)

Angers, Maine-et-Loire 49055

France

Centre de Cancerologie Les Dentellieres ( Site 1306)

Valenciennes, Nord 59300

France

Centre Hospitalier de Pau ( Site 1302)

Pau, Pyrenees-Atlantiques 64046

France

Centre Henri Becquerel ( Site 1319)

Rouen, Seine-Maritime 76038

France

Hôpital Tenon ( Site 1303)

Paris, 75020

France

Praxis fuer interdisziplinaere Onkologie und Haematologie ( Site 1423)

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)

Ludwigsburg, Baden-Wurttemberg 71640

Germany

Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)

Tübingen, Baden-Wurttemberg 72076

Germany

Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)

Erlangen, Bavaria 91054

Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)

Munich, Bavaria 80336

Germany

Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)

Potsdam, Brandenburg 14467

Germany

Franziskus-Hospital Harderberg ( Site 1404)

Georgsmarienhütte, Lower Saxony 49124

Germany

Medizinische Hochschule Hannover ( Site 1419)

Hanover, Lower Saxony 30625

Germany

Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)

Düsseldorf, North Rhine-Westphalia 40225

Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)

Essen, North Rhine-Westphalia 45136

Germany

Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)

Mönchengladbach, North Rhine-Westphalia 41061

Germany

Marien Hospital Witten ( Site 1424)

Witten, North Rhine-Westphalia 58452

Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)

Mainz, Rhineland-Palatinate 55131

Germany

Klinikum Mutterhaus der Borromäerinnen ( Site 1420)

Trier, Rhineland-Palatinate 54290

Germany

CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)

Saarbrücken, Saarland 66113

Germany

Universitätsklinikum Schleswig-Holstein ( Site 1411)

Lübeck, Schleswig-Holstein 23538

Germany

Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)

Berlin, 13125

Germany

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)

Pátrai, Achaia 26504

Greece

Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)

Athens, Attica 115 26

Greece

Aretaieio Hospital Oncology Unit ( Site 1505)

Athens, Attica 115 28

Greece

University General Hospital of Larissa ( Site 1503)

Larissa, Thessaly 411 10

Greece

European Interbalkan Medical Center ( Site 1502)

Thessaloniki, 570 01

Greece

European Interbalkan Medical Center ( Site 1507)

Thessaloniki, 570 01

Greece

Queen Mary Hospital ( Site 3600)

Hong Kong,

Hong Kong

Hong Kong United Oncology Centre ( Site 3601)

Kowloon,

Hong Kong

Prince of Wales Hospital ( Site 3602)

Shatin, 000000

Hong Kong

Bon Secours Cork Hospital ( Site 1600)

Cork, T12 DV56

Ireland

St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)

Dublin, D04 T6F4

Ireland

University College Hospital - Galway ( Site 1602)

Galway, Galway

Ireland

Soroka Medical Center-Oncology ( Site 1704)

Beersheba, 8410101

Israel

Shaare Zedek Medical Center ( Site 1706)

Jerusalem, 9103102

Israel

Hadassah Medical Center ( Site 1700)

Jerusalem, 9112001

Israel

Rabin Medical Center ( Site 1702)

Petah Tikva, 4941492

Israel

Sheba Medical Center-ONCOLOGY ( Site 1701)

Ramat Gan, 5265601

Israel

Sourasky Medical Center ( Site 1705)

Tel Aviv, 6423906

Israel

University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)

Naples, Campania 80100

Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)

Naples, Campania 80131

Italy

Humanitas Istituto Clinico Catanese ( Site 1811)

Misterbianco, Catania 95045

Italy

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)

Meldola (FC), Forli-Cesena 47014

Italy

CRO-IRCCS ( Site 1808)

Aviano, Friuli Venezia Giulia 33081

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)

Rome, Lazio 00168

Italy

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)

Brescia, Lombardy 25123

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)

Milan, Lombardy 20133

Italy

Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)

Milan, Lombardy 20141

Italy

Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)

Monza, Lombardy 20900

Italy

Azienda Ospedaliera Universitaria Careggi ( Site 1805)

Florence, Tuscany 50134

Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)

Bologna, 40138

Italy

Ospedale San Raffaele-Oncologia Medica ( Site 1814)

Milan, 20132

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)

Novara, 28100

Italy

Nagoya City University Hospital ( Site 3414)

Nagoya, Aichi-ken 467-8602

Japan

National Cancer Center Hospital East ( Site 3403)

Kashiwa, Chiba 277-8577

Japan

Gunma Prefectural Cancer Center ( Site 3428)

Ōta, Gunma 373-8550

Japan

Hokkaido University Hospital ( Site 3400)

Sapporo, Hokkaido 060-8648

Japan

Tokai University Hospital ( Site 3413)

Isehara, Kanagawa 259-1193

Japan

St. Marianna University Hospital ( Site 3405)

Kawasaki, Kanagawa 216-8511

Japan

Kitasato University Hospital ( Site 3411)

Sagamihara, Kanagawa 252-0375

Japan

Kanagawa Cancer Center ( Site 3412)

Yokohama, Kanagawa 241-8515

Japan

Mie University Hospital ( Site 3423)

Tsu, Mie-ken 514-8507

Japan

Tohoku University Hospital ( Site 3422)

Sendai, Miyagi 980-8574

Japan

The University of Osaka Hospital ( Site 3416)

Suita, Osaka 565-0871

Japan

Saitama Medical University International Medical Center ( Site 3402)

Hidaka, Saitama 350-1298

Japan

Juntendo University Hospital ( Site 3408)

Bunkyo, Tokyo 113-8431

Japan

St.Luke's International Hospital ( Site 3427)

Chūō, Tokyo 104-8560

Japan

Cancer Institute Hospital of JFCR ( Site 3404)

Koto, Tokyo 135-8550

Japan

Showa Medical University Hospital ( Site 3406)

Shinagawa, Tokyo 142-8666

Japan

Tokyo Medical University Hospital ( Site 3407)

Shinjuku, Tokyo 160-0023

Japan

National Center for Global Health and Medicine ( Site 3409)

Shinjuku, Tokyo 162-8655

Japan

Fukushima Medical University Hospital ( Site 3401)

Fukushima, 960-1295

Japan

Gifu University Hospital ( Site 3426)

Gifu, 501-1194

Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 3418)

Hiroshima, 730-8518

Japan

Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)

Kagoshima, 892-0833

Japan

Kumamoto University Hospital ( Site 3420)

Kumamoto, 860-8556

Japan

Kyoto University Hospital ( Site 3415)

Kyoto, 606-8507

Japan

Okayama University Hospital ( Site 3425)

Okayama, 700-8558

Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)

Osaka, 541-8567

Japan

Prince Court Medical Centre ( Site 2802)

Kuala Lumpur, 50450

Malaysia

Pantai Hospital Kuala Lumpur ( Site 2801)

Kuala Lumpur, 59100

Malaysia

CENEIT Oncologicos ( Site 0706)

Mexico City, Mexico City 03100

Mexico

Grupo Médico ASSET ( Site 0705)

Mexico City, Mexico City 03100

Mexico

Health Pharma Professional Research S.A. de C.V: ( Site 0709)

Mexico City, Mexico City 03100

Mexico

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)

Mexico City, Mexico City 04700

Mexico

Oncare - Unidad Valle ( Site 0713)

San Pedro Garza García, Nuevo León 66220

Mexico

CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)

San Pedro Garza García, Nuevo León 66278

Mexico

Drammen Sykehus, Vestre Viken HF ( Site 2001)

Drammen, Buskerud 3004

Norway

Stavanger Universitetssykehus ( Site 2004)

Stavanger, Rogaland 4011

Norway

Oslo universitetssykehus, Radiumhospitalet ( Site 2002)

Oslo, 0379

Norway

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)

Krakow, Lesser Poland Voivodeship 31-115

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)

Warsaw, Masovian Voivodeship 02-781

Poland

Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)

Wieliszew, Masovian Voivodeship 05-135

Poland

Bialostockie Centrum Onkologii ( Site 2105)

Bialystok, Podlaskie Voivodeship 15-027

Poland

Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)

Gdynia, Pomeranian Voivodeship 81-519

Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)

Gliwice, Silesian Voivodeship 44-102

Poland

Zachodniopomorskie Centrum Onkologii ( Site 2108)

Szczecin, West Pomeranian Voivodeship 71-730

Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)

Kielce, Świętokrzyskie Voivodeship 25-734

Poland

Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)

Amadora, Lisbon District 2720-276

Portugal

Fundacao Champalimaud ( Site 2200)

Lisbon, 1400-038

Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)

Lisbon, 1649-035

Portugal

Instituto Portugues de Oncologia do Porto ( Site 2202)

Porto, 4200-072

Portugal

National Cancer Centre Singapore-Medical Oncology ( Site 3002)

Singapore, Central Singapore 168583

Singapore

Seoul National University Hospital-Internal Medicine ( Site 3102)

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)

Seoul, 03722

South Korea

Asan Medical Center-Department of Oncology ( Site 3103)

Seoul, 05505

South Korea

Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)

Seoul, 06273

South Korea

Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)

Seoul, 06351

South Korea

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)

Seville, Andalusia 41013

Spain

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)

L'Hospitalet de Llobregat, Barcelona 08908

Spain

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)

A Coruña, La Coruna 15006

Spain

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)

Madrid, Madrid, Comunidad de 28034

Spain

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)

Majadahonda, Madrid, Comunidad de 28222

Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)

Valencia, Valenciana, Comunitat 46009

Spain

Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)

Barcelona, 08035

Spain

Hospital Beata María Ana-oncology ( Site 2309)

Madrid, 28007

Spain

Hospital Clinico San Carlos-Oncology Department ( Site 2306)

Madrid, 28040

Spain

HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)

Valencia, 46010

Spain

Gävle sjukhus ( Site 3504)

Gävle, Gävleborg County 801 87

Sweden

Capio St. Gorans Sjukhus ( Site 3503)

Stockholm, Stockholm County 112 81

Sweden

Karolinska Universitetssjukhuset Solna ( Site 3500)

Stockholm, Stockholm County 171 76

Sweden

Akademiska Sjukhuset ( Site 3501)

Uppsala, Uppsala County 751 85

Sweden

Södra Älvsborg Sjukhus ( Site 3502)

Borås, Västra Götaland County 501 82

Sweden

Sahlgrenska Universitetssjukhuset. ( Site 3505)

Gothenburg, Västra Götaland County 413 45

Sweden

Spital Thun ( Site 2400)

Thun, Canton of Bern 3600

Switzerland

Clinique Générale-Beaulieu ( Site 2406)

Geneva, Canton of Geneva 1206

Switzerland

Brust-Zentrum ( Site 2401)

Zurich, Canton of Zurich 8008

Switzerland

Kantonsspital Graubünden-Medizin ( Site 2404)

Chur, Kanton Graubünden 7000

Switzerland

HFR Fribourg - Hôpital Cantonal ( Site 2402)

Fribourg, 1708

Switzerland

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)

Adana, 01140

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)

Ankara, 06200

Turkey (Türkiye)

Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)

Ankara, 06520

Turkey (Türkiye)

Medipol Mega Universite Hastanesi-oncology ( Site 2503)

Istanbul, 34214

Turkey (Türkiye)

Samsun Medical Park Hastanesi-medical oncology ( Site 2500)

Samsun, 55200

Turkey (Türkiye)

University Hospitals Bristol NHS Foundation Trust ( Site 2601)

Bristol, Bristol, City of BS2 8ED

United Kingdom

The Royal Cornwall Hospital ( Site 2603)

Truro, England TR1 3LJ

United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)

London, London, City of EC1A 7BE

United Kingdom

University College London Hospital ( Site 2604)

London, London, City of NW1 2PG

United Kingdom

Western General Hospital ( Site 2607)

Edinburgh, Midlothian EH4 2XU

United Kingdom

St James's University Hospital-Leeds Cancer Centre ( Site 2608)

Leeds, LS9 7TF

United Kingdom