A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

May 20, 2026 updated by: Merck Sharp & Dohme LLC

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.

The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman-Oncology ( Site 0386)
        • Contact:
          • Study Coordinator
          • Phone Number: 541148277000 #3036
      • Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)
        • Contact:
          • Study Coordinator
          • Phone Number: 52990100
      • Córdoba, Argentina, X5004BAL
        • Recruiting
        • Hospital Italiano de Córdoba ( Site 0385)
        • Contact:
          • Study Coordinator
          • Phone Number: +543514106500
      • La Rioja, Argentina, F5300COE
        • Recruiting
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)
        • Contact:
          • Study Coordinator
          • Phone Number: 543804436443 x108
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0382)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos-Oncology ( Site 0384)
        • Contact:
          • Study Coordinator
          • Phone Number: +543412221472
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298122956
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +61288905200
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Completed
        • Frankston Hospital-Oncology and Haematology ( Site 2003)
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital-Medical Oncology ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +61861526530
      • Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: 3281423849
    • Bruxelles-Capitale, Region de
      • Anderlecht, Bruxelles-Capitale, Region de, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet-Medicine Oncology ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 2 541 72 51
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +3227645106
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +3211337990
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares-IKG ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: 09 246 95 23
      • São Paulo, Brazil, 04014-012
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +551144500300
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: +5586999007799
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133142965
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Recruiting
        • Hospital do Câncer Mãe de Deus ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133072943
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
        • Recruiting
        • Instituto de Oncologia Saint Gallen ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: +55513056-8686
    • São Paulo
      • Taubaté, São Paulo, Brazil, 12030-200
        • Recruiting
        • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: +551236318559
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Recruiting
        • BC Cancer Surrey ( Site 0315)
        • Contact:
          • Study Coordinator
          • Phone Number: 604-930-2098
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Active, not recruiting
        • Southlake Health ( Site 0311)
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-5605
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-252-3400 x5370
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-340-8222
      • Québec, Quebec, Canada, G1S 4L8
        • Recruiting
        • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 418-682-7511
      • Rimouski, Quebec, Canada, G5L 5T1
        • Recruiting
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)
        • Contact:
          • Study Coordinator
          • Phone Number: 418 724-3000 x8029
      • Antofagasta, Chile, 1263521
        • Recruiting
        • Bradford Hill Norte ( Site 0456)
        • Contact:
          • Study Coordinator
          • Phone Number: 56442023631
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0451)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 7500994
        • Recruiting
        • Oncovida ( Site 0453)
        • Contact:
          • Study Coordinator
          • Phone Number: 56226023875
      • Santiago, Region M. de Santiago, Chile, 7650018
        • Recruiting
        • Clínica RedSalud Vitacura ( Site 0455)
        • Contact:
          • Study Coordinator
          • Phone Number: 56223954044
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0452)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
      • Santiago, Region M. de Santiago, Chile, 832000
        • Recruiting
        • Pontificia Universidad Catolica de Chile ( Site 0454)
        • Contact:
          • Study Coordinator
          • Phone Number: +56934331806
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Recruiting
        • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3147362301
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 6017454421x90614
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Recruiting
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: + 57 317 515 0103
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 23002
        • Recruiting
        • IMAT S.A.S ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: + 57 320 566 9416
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023319090 - 4022
      • San José, Costa Rica, 10108
        • Recruiting
        • ICIMED ( Site 0552)
        • Contact:
          • Study Coordinator
          • Phone Number: +50688317449
    • Provincia de San José
      • San José, Provincia de San José, Costa Rica, 10103
        • Recruiting
        • CIMCA ( Site 0551)
        • Contact:
          • Study Coordinator
          • Phone Number: +50683893636
      • Santa Ana, Provincia de San José, Costa Rica, 10903
        • Active, not recruiting
        • Hospital Metropolitano - Sede Lindora ( Site 0550)
      • Prague, Czechia, 100 34
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady-Onkologická klinika ( Site 1135)
        • Contact:
          • Study Coordinator
          • Phone Number: +420267163562
    • Moravian-Silesian Region
      • Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 1134)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597372124
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588444295
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224434700
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Czechia, 370 01
        • Recruiting
        • Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138)
        • Contact:
          • Study Coordinator
          • Phone Number: +420387875001
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 1180)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
      • Hillerød, Capital Region, Denmark, 3400
        • Recruiting
        • Nordsjællands Hospital - Hillerød ( Site 1184)
        • Contact:
          • Study Coordinator
          • Phone Number: +4548294829
    • Region Sjælland
      • Næstved, Region Sjælland, Denmark, 4700
        • Recruiting
        • Næstved Sygehus ( Site 1182)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 56512000
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 1181)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 66113333
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Vejle Sygehus ( Site 1183)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 79405000
      • Paris, France, 75248
        • Recruiting
        • Institut Curie-Oncology medical Department ( Site 1240)
        • Contact:
          • Study Coordinator
          • Phone Number: +33144324675
      • Paris, France, 75013
        • Recruiting
        • Pitie Salpetriere University Hospital ( Site 1249)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142160097
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Recruiting
        • Hopital Prive Jean Mermoz-Oncology ( Site 1246)
        • Contact:
          • Study Coordinator
          • Phone Number: 33437538725
    • Calvados
      • Caen, Calvados, France, 14076
        • Recruiting
        • Centre François Baclesse ( Site 1250)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231455050
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Recruiting
        • Centre de Cancérologie du Grand Montpellier ( Site 1244)
        • Contact:
          • Study Coordinator
          • Phone Number: 0430298723
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44277
        • Recruiting
        • Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)
        • Contact:
          • Study Coordinator
          • Phone Number: 33228272088
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)
        • Contact:
          • Study Coordinator
          • Phone Number: 33549444548
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930940113394
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318533572
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann-Frauenklinik ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: +493312415602
    • Lower Saxony
      • Georgsmarienhütte, Lower Saxony, Germany, 49124
        • Recruiting
        • Franziskus-Hospital Harderberg ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +495415022466
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +492118117506
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +4920117433005
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • Recruiting
        • CaritasKlinikum Saarbruecken St. Theresia ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +496814061345
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315)
        • Contact:
          • Study Coordinator
          • Phone Number: +493658287758
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center ( Site 1341)
        • Contact:
          • Study Coordinator
          • Phone Number: +302313252011
      • Thessaloniki, Greece, 552 36
        • Recruiting
        • St. LUKE'S HOSPITAL S.A. ( Site 1347)
        • Contact:
          • Study Coordinator
          • Phone Number: +302310390671
    • Attica
      • Athens, Attica, Greece, 115 26
        • Recruiting
        • Errikos Dunant Hospital Center ( Site 1348)
        • Contact:
          • Study Coordinator
          • Phone Number: +302106972433
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • Aretaieio Hospital Oncology Unit ( Site 1345)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107286444
      • Marousi, Attica, Greece, 151 23
        • Recruiting
        • Hygeia Hospital ( Site 1346)
        • Contact:
          • Study Coordinator
          • Phone Number: +302106867165
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa ( Site 1343)
        • Contact:
          • Study Coordinator
          • Phone Number: +302413502785
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 2040)
        • Contact:
          • Study Coordinator
          • Phone Number: QMH- +852 2255 3838
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital ( Site 2041)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 3505 2211
      • Budapest, Hungary, 1145
        • Recruiting
        • Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)
        • Contact:
          • Study Coordinator
          • Phone Number: +36209674709
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381)
        • Contact:
          • Study Coordinator
          • Phone Number: 36208258821
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652255585
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)
        • Contact:
          • Study Coordinator
          • Phone Number: 3662545404
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Recruiting
        • Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)
        • Contact:
          • Study Coordinator
          • Phone Number: 36304111268
    • Zala County
      • Zalaegerszeg, Zala County, Hungary, 8900
        • Recruiting
        • Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)
        • Contact:
          • Study Coordinator
          • Phone Number: 36304199969
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital-Medical Oncology ( Site 2053)
        • Contact:
          • Study Coordinator
          • Phone Number: 9967111418
      • Mumbai, Maharashtra, India, 400053
        • Completed
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056)
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences ( Site 2051)
        • Contact:
          • Study Coordinator
          • Phone Number: 504326588500
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052)
        • Contact:
          • Study Coordinator
          • Phone Number: 8005328138
      • Cork, Ireland, T12 DV56
        • Recruiting
        • Bon Secours Cork Hospital ( Site 1422)
        • Contact:
          • Study Coordinator
          • Phone Number: +353214542807
      • Dublin, Ireland, D07 R2WY
        • Recruiting
        • Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423)
        • Contact:
          • Study Coordinator
          • Phone Number: +353018034834
      • Dublin, Ireland, D04 T6F4
        • Recruiting
        • St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420)
        • Contact:
          • Study Coordinator
          • Phone Number: +353012214000
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 1452)
        • Contact:
          • Study Coordinator
          • Phone Number: 04-7776234
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 1451)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-6777111
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1453)
        • Contact:
          • Study Coordinator
          • Phone Number: 039378076
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1450)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35304436
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0512144548
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale San Martino ( Site 1479)
        • Contact:
          • Study Coordinator
          • Phone Number: +390105600387
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 1471)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226436530
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)
        • Contact:
          • Study Coordinator
          • Phone Number: +3930156318
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480)
        • Contact:
          • Study Coordinator
          • Phone Number: +390543739100
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • CRO-IRCCS ( Site 1478)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0434659514
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223902849
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)
        • Contact:
          • Study Coordinator
          • Phone Number: +02 57489970
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas ( Site 1476)
        • Contact:
          • Study Coordinator
          • Phone Number: +390282244080
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 2461)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1111
      • Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital ( Site 2486)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-58-230-6000
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital ( Site 2478)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-221-2291
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Social medical corporation Hakuaikai Sagara Hospital ( Site 2481)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-224-1800
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital ( Site 2480)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-344-2111
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital ( Site 2475)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-751-4389
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 2485)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2477)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital ( Site 2474)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-858-7215
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 2463)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 2460)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital ( Site 2473)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-463-93-1121
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 2465)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital ( Site 2471)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-778-9965
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 2472)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 2483)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-59-231-5246
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 2482)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital ( Site 2476)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6210-8290
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 2462)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 2468)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 2464)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinagawa, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa Medical University Hospital ( Site 2466)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3784-8000
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 2467)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 2469)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Pantai Hospital Kuala Lumpur ( Site 2151)
        • Contact:
          • Study Coordinator
          • Phone Number: +60327814519
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Recruiting
        • Hospital Sultan Ismail ( Site 2153)
        • Contact:
          • Study Coordinator
          • Phone Number: +6073565155
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital ( Site 2154)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276820
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)
        • Contact:
          • Study Coordinator
          • Phone Number: +523332592394
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Grupo Médico ASSET-Clinical Research ( Site 0596)
        • Contact:
          • Study Coordinator
          • Phone Number: +52155551013316
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A. de C.V: ( Site 0598)
        • Contact:
          • Study Coordinator
          • Phone Number: +525575864856
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • INCAN-TUMORES MAMARIOS ( Site 0597)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 55 5451 4847
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590)
      • San Pedro Garza García, Nuevo León, Mexico, 66278
        • Active, not recruiting
        • CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595)
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Recruiting
        • Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)
        • Contact:
          • Study Coordinator
          • Phone Number: +31880056201
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+-Medical Oncology ( Site 1522)
        • Contact:
          • Study Coordinator
          • Phone Number: +31433877025
    • North Brabant
      • Breda, North Brabant, Netherlands, 4800 RK
        • Recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)
        • Contact:
          • Study Coordinator
          • Phone Number: +31765952408
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Recruiting
        • Catharina Ziekenhuis ( Site 1526)
        • Contact:
          • Study Coordinator
          • Phone Number: +31402396622
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)
        • Contact:
          • Study Coordinator
          • Phone Number: +31205129111
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Recruiting
        • Isala, locatie Zwolle ( Site 1525)
        • Contact:
          • Study Coordinator
          • Phone Number: +31886246040
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum ( Site 1521)
        • Contact:
          • Study Coordinator
          • Phone Number: +31338507278
      • Auckland, New Zealand, 1023
        • Active, not recruiting
        • Auckland City Hospital ( Site 2031)
      • Lima, Peru, 15036
        • Active, not recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)
    • Ariqipa
      • Arequipa, Ariqipa, Peru, 15036
        • Active, not recruiting
        • Clinica Vallesur - AUNA ( Site 0652)
    • Lima
      • Jesús María, Lima, Peru, 18
        • Active, not recruiting
        • Hospital Militar Central Luis Arias Schereiber ( Site 0651)
    • Muni Metro de Lima
      • Lima, Muni Metro de Lima, Peru, 15036
        • Active, not recruiting
        • Oncosalud ( Site 0650)
    • Davao Del Sur
      • Davao City, Davao Del Sur, Philippines, 8000
        • Recruiting
        • Metro Davao Medical and Research Center ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: (082) - 287-7777
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1102
        • Recruiting
        • ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 09498889607
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523743525
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)
        • Contact:
          • Study Coordinator
          • Phone Number: +4825640372
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462000
      • Wieliszew, Masovian Voivodeship, Poland, 05-135
        • Active, not recruiting
        • Mazowiecki Szpital Onkologiczny ( Site 1581)
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
        • Recruiting
        • Mrukmed-Mrukmed ( Site 1592)
        • Contact:
          • Study Coordinator
          • Phone Number: +48178530728
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 1585)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856646888
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Active, not recruiting
        • Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590)
        • Contact:
          • Study Coordinator
          • Phone Number: +48322788721
    • West Pomeranian Voivodeship
      • Poland, West Pomeranian Voivodeship, Poland, 75-581
        • Active, not recruiting
        • Szpital Wojewódzki w Koszalinie. ( Site 1583)
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-730
        • Completed
        • Zachodniopomorskie Centrum Onkologii ( Site 1588)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Active, not recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595)
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217805000
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351225084000
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 2720-276
        • Recruiting
        • Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351214348200
      • Hato Rey, Puerto Rico, 00917
        • Completed
        • Puerto Rico Medical Research Center LLC ( Site 0675)
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
        • Contact:
          • Study Coordinator
          • Phone Number: 7877728300 Ext 1226
      • Bucharest, Romania, 077190
        • Recruiting
        • Centrul Medical Neolife- Baneasa ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040217948731
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040264598362
    • Bucharest
      • Bucharest, Bucharest, Romania, 011171
        • Recruiting
        • Spitalul Clinic Filantropia ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040213188930
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040219368
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital ( Site 2250)
        • Contact:
          • Study Coordinator
          • Phone Number: +6569082222
    • North East
      • Singapore, North East, Singapore, 574623
        • Recruiting
        • Mount Alvernia ICON Cancer Center ( Site 2251)
        • Contact:
          • Study Coordinator
          • Phone Number: +6562550528
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • Recruiting
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: 041 450 6152
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Wits Clinical Research ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +27113390600
      • Pretoria, Gauteng, South Africa, 0084
        • Recruiting
        • Curo Oncology ( Site 2908)
        • Contact:
          • Study Coordinator
          • Phone Number: +27123356771
      • Sandton, Gauteng, South Africa, 2196
        • Recruiting
        • Sandton Oncology Medical Group (Pty) Ltd ( Site 2911)
        • Contact:
          • Study Coordinator
          • Phone Number: +27118830900
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • Cancercare Rondebosch Oncology-Clinical trials ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: +279443700
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital-Internal Medicine ( Site 2353)
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)
        • Contact:
          • Study Coordinator
          • Phone Number: 82222288135
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Department of Oncology ( Site 2352)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230105397
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)
        • Contact:
          • Study Coordinator
          • Phone Number: 82234106833
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)
        • Contact:
          • Study Coordinator
          • Phone Number: +34957511464
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Beata María Ana-oncology ( Site 1755)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914097423
      • Madrid, Spain, 28009
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)
        • Contact:
          • Study Coordinator
          • Phone Number: +3491 426 93 92
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena ( Site 1757)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955008000
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961973583
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +46812370000
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Recruiting
        • Akademiska sjukhuset ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +46186110000
    • Västra Götaland County
      • Borås, Västra Götaland County, Sweden, 501 82
        • Recruiting
        • Södra Älvsborgs Sjukhus Borås ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +46336161000
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Recruiting
        • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)
        • Contact:
          • Study Coordinator
          • Phone Number: +41613284214
    • Canton of Bern
      • Thun, Canton of Bern, Switzerland, 3600
        • Recruiting
        • Spital Thun ( Site 1840)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 58 636 22 27
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8008
        • Recruiting
        • Brust-Zentrum ( Site 1841)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 44 533 81 05
      • Changhua, Taiwan, 50006
        • Completed
        • Changhua Christian Hospital ( Site 2410)
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123x3267
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Surgery ( Site 2411)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital ( Site 2412)
        • Contact:
          • Study Coordinator
          • Phone Number: +886225433535
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 2415)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-23123456x71673
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200x3219
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876)
        • Contact:
          • Study Coordinator
          • Phone Number: 905056166338
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123054330 (9264)
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 1874)
        • Contact:
          • Study Coordinator
          • Phone Number: 00905067521275
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125526000/622111
      • Istanbul, Turkey (Türkiye), 34722
        • Completed
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872)
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1873)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 362 311 40 40
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090 506 366 5181
    • Istanbul
      • Stanbul, Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 1875)
        • Contact:
          • Study Coordinator
          • Phone Number: 4447044
      • Blackpool, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital ( Site 1941)
        • Contact:
          • Study Coordinator
          • Phone Number: 01253 951524
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
        • Contact:
          • Study Coordinator
          • Phone Number: 441159691169
    • Derry and Strabane
      • Londonderry, Derry and Strabane, United Kingdom, BT47 6SB
        • Recruiting
        • North West Cancer Centre ( Site 1944)
        • Contact:
          • Study Coordinator
          • Phone Number: 02871320781
    • England
      • Truro, England, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital ( Site 1943)
        • Contact:
          • Study Coordinator
          • Phone Number: +441872258343
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Centers ( Site 0066)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-821-2838
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center-Oncology ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-256-6444
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation-Oncology ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-446-5900
      • La Jolla, California, United States, 92093-0698
        • Active, not recruiting
        • Moores Cancer Center ( Site 0059)
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Cancer and Blood Specialty Clinic ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 562-353-1200
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-724-6077
      • Denver, Colorado, United States, 80206
        • Recruiting
        • UCHealth Cherry Creek Medical Center ( Site 0094)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-1030
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-1030
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center ( Site 0060)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-688-4242
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Stamford Hospital ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-276-1000
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Altamonte Springs ( Site 0021)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-834-5151
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine ( Site 0063)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-265-0725
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-843-8370
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
        • Contact:
          • Study Coordinator
          • Phone Number: 229-584-5400
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 0067)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-6149
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush University Medical Center ( Site 0079)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-942-3498
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-301-4245
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70817
        • Recruiting
        • Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-501-4763
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Comprehensive Cancer Center ( Site 0036)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-328-6373
      • Baltimore, Maryland, United States, 21202
        • Completed
        • Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital ( Site 0073)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-754-7000
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 857-215-3246
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-916-2576
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute ( Site 0027)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-932-2677
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-454-8313
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • NYU Langone Health - Brooklyn ( Site 0089)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Associates of Rockland ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 845-362-1750
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University-Cancer Center ( Site 0034)
        • Contact:
          • Study Coordinator
          • Phone Number: 631-444-4392
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 980-442-2000
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Completed
        • Zangmeister Cancer Center ( Site 7000)
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center ( Site 0044)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-215-2619
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center ( Site 0081)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-215-2619
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-955-8874
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-265-2080
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 0050)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-648-3111
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Health and Hospital System ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-590-8000
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • The Center for Cancer and Blood Disorders ( Site 0041)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-759-7000
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-241-0493
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-595-7093
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 0025)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-472-4724
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-594-7300
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 0070)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-462-7739
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 844-482-4812
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-622-8922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  • Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
  • Is a chemotherapy candidate
  • Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
  • Has adequate organ function
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

  • Has breast cancer amenable to treatment with curative intent
  • Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
  • Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
  • Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm C: Treatment of Physician's Choice (TPC)
At the physician's discretion, participants receive chemotherapy of 80 mg/m^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
IV infusion
Other Names:
  • TAXOL®
IV infusion
Other Names:
  • ABRAXANE®
oral tablet
Other Names:
  • XELODA®
IV infusion
Other Names:
  • DOXIL®
Experimental: Arm A: Sacituzumab tirumotecan
Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
IV infusion
Other Names:
  • MK-2870
Experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan
Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to ~2 years).
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
IV infusion
Other Names:
  • MK-2870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
Time Frame: Up to ~38 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to ~38 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~77 months
OS is defined as the time from randomization to death due to any cause.
Up to ~77 months
Objective Response Rate (ORR)
Time Frame: Up to ~57 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to ~57 months
Duration of Response (DOR)
Time Frame: Up to ~57 months
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to ~57 months
Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Baseline and up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Baseline and up to ~77 months
Change from baseline in physical functioning score, on the EORTC QLQ-C30
Time Frame: Baseline and up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.
Baseline and up to ~77 months
Change from baseline in emotional functioning score, on the EORTC QLQ-C30
Time Frame: Baseline and up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning.
Baseline and up to ~77 months
Change from baseline in fatigue score, on the EORTC QLQ-C30
Time Frame: Baseline and up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
Baseline and up to ~77 months
Change from baseline in diarrhea score, on the EORTC QLQ-C30
Time Frame: Baseline and up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
Baseline and up to ~77 months
Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
Time Frame: Up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in global health status/quality of life combined score.
Up to ~77 months
TTD in physical functioning score, on the EORTC QLQ-C30
Time Frame: Up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the physical functioning score.
Up to ~77 months
TTD in emotional functioning score, on the EORTC QLQ-C30
Time Frame: Up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning. TD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the emotional functioning score.
Up to ~77 months
TTD in fatigue score, on the EORTC QLQ-C30
Time Frame: Up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the fatigue score.
Up to ~77 months
TTD in diarrhea score, on the EORTC QLQ-C30
Time Frame: Up to ~77 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question about their diarrhea are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the diarrhea score.
Up to ~77 months
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~77 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~77 months
Number of participants who discontinue study treatment due to an AE
Time Frame: Up to ~77 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~77 months
Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
Time Frame: Up to ~57 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to ~57 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2024

Primary Completion (Estimated)

July 11, 2027

Study Completion (Estimated)

April 12, 2031

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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