AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT06312176

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)

A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Paclitaxel in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC at 259 sites in 40 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Sacituzumab tirumotecan, Pembrolizumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
259 sitesin 40 countries
Study dates
14 Apr 2024to 12 Apr 2031
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

259 sites in 40 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

259 sites in 40 countries

United States46 sites, 37 recruiting

  • AdventHealth Altamonte Springs ( Site 0021)

    Altamonte Springs, Florida, 32701

    Study Coordinator, 407-834-5151

    Recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0061)

    Aurora, Colorado, 80045

    Study Coordinator, 303-724-6077

    Recruiting

  • Greenebaum Comprehensive Cancer Center ( Site 0036)

    Baltimore, Maryland, 21201

    Study Coordinator, 410-328-6373

    Recruiting

  • Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)

    Baltimore, Maryland, 21202

    Completed

  • Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)

    Baton Rouge, Louisiana, 70817

    Study Coordinator, 888-501-4763

    Recruiting

  • Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)

    Boston, Massachusetts, 02215

    Study Coordinator, 857-215-3246

    Recruiting

  • NYU Langone Health - Brooklyn ( Site 0089)

    Brooklyn, New York, 11220

    Study Coordinator, 212-731-6000

    Recruiting

  • Ironwood Cancer & Research Centers ( Site 0066)

    Chandler, Arizona, 85224

    Study Coordinator, 480-821-2838

    Recruiting

  • Levine Cancer Institute ( Site 0014)

    Charlotte, North Carolina, 28204

    Study Coordinator, 980-442-2000

    Recruiting

  • Rush University Medical Center ( Site 0079)

    Chicago, Illinois, 60607

    Study Coordinator, 312-942-3498

    Recruiting

  • University of Chicago Medical Center ( Site 0067)

    Chicago, Illinois, 60637

    Active, not recruiting

  • Zangmeister Cancer Center ( Site 7000)

    Columbus, Ohio, 43219

    Completed

  • Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)

    Dallas, Texas, 75231

    Study Coordinator, 214-265-2080

    Recruiting

  • Parkland Health and Hospital System ( Site 0069)

    Dallas, Texas, 75235

    Study Coordinator, 214-590-8000

    Recruiting

  • UT Southwestern Medical Center ( Site 0050)

    Dallas, Texas, 75390

    Study Coordinator, 214-648-3111

    Recruiting

  • UCHealth Cherry Creek Medical Center ( Site 0094)

    Denver, Colorado, 80206

    Study Coordinator, 720-848-1030

    Recruiting

  • Henry Ford Health ( Site 0002)

    Detroit, Michigan, 48202

    Study Coordinator, 313-916-2576

    Recruiting

  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)

    Edgewood, Kentucky, 41017

    Study Coordinator, 859-301-4245

    Recruiting

  • Inova Schar Cancer Institute ( Site 0025)

    Fairfax, Virginia, 22031

    Study Coordinator, 571-472-4724

    Recruiting

  • The Center for Cancer and Blood Disorders ( Site 0041)

    Fort Worth, Texas, 76104

    Study Coordinator, 817-759-7000

    Recruiting

  • Providence Medical Foundation-Oncology ( Site 0020)

    Fullerton, California, 92835

    Study Coordinator, 714-446-5900

    Recruiting

  • University of Florida College of Medicine ( Site 0063)

    Gainesville, Florida, 32610

    Active, not recruiting

  • Banner MD Anderson Cancer Center-Oncology ( Site 0004)

    Gilbert, Arizona, 85234

    Study Coordinator, 480-256-6444

    Recruiting

  • University of Colorado Health - Highlands Ranch Hospital ( Site 0095)

    Highlands Ranch, Colorado, 80129

    Completed

  • Saint Luke's Cancer Institute ( Site 0027)

    Kansas City, Missouri, 64111

    Study Coordinator, 816-932-2677

    Recruiting

  • Moores Cancer Center ( Site 0059)

    La Jolla, California, 92093-0698

    Active, not recruiting

  • Cancer and Blood Specialty Clinic ( Site 0001)

    Los Alamitos, California, 90720

    Active, not recruiting

  • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)

    Madison, Wisconsin, 53792

    Study Coordinator, 800-622-8922

    Recruiting

  • Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)

    Midlothian, Virginia, 23114

    Study Coordinator, 804-594-7300

    Recruiting

  • NYU Langone Hospital - Long Island ( Site 0090)

    Mineola, New York, 11501

    Study Coordinator, 212-731-6000

    Recruiting

  • Yale Cancer Center ( Site 0060)

    New Haven, Connecticut, 06510

    Active, not recruiting

  • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)

    New York, New York, 10016

    Study Coordinator, 212-731-6000

    Recruiting

  • Hematology Oncology Associates of Rockland ( Site 0054)

    Nyack, New York, 10960

    Study Coordinator, 845-362-1750

    Recruiting

  • Orlando Health Cancer Institute ( Site 0011)

    Orlando, Florida, 32806

    Study Coordinator, 321-843-8370

    Recruiting

  • Thomas Jefferson University - Clinical Research Institute ( Site 0056)

    Philadelphia, Pennsylvania, 19107

    Study Coordinator, 215-955-8874

    Recruiting

  • Providence Portland Medical Center ( Site 0044)

    Portland, Oregon, 97213

    Study Coordinator, 503-215-2619

    Recruiting

  • Providence St. Vincent Medical Center ( Site 0081)

    Portland, Oregon, 97225

    Study Coordinator, 503-215-2619

    Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0070)

    Richmond, Virginia, 23219

    Study Coordinator, 877-462-7739

    Recruiting

  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)

    Roanoke, Virginia, 24014

    Study Coordinator, 844-482-4812

    Recruiting

  • Texas Oncology - San Antonio ( Site 8002)

    San Antonio, Texas, 78240

    Study Coordinator, 212-241-0493

    Recruiting

  • Holy Cross Hospital ( Site 0073)

    Silver Spring, Maryland, 20910

    Study Coordinator, 301-754-7000

    Recruiting

  • Washington University School of Medicine ( Site 0076)

    St Louis, Missouri, 63110

    Study Coordinator, 314-454-8313

    Recruiting

  • Stamford Hospital ( Site 0049)

    Stamford, Connecticut, 06902

    Study Coordinator, 203-276-1000

    Recruiting

  • Stony Brook University-Cancer Center ( Site 0034)

    Stony Brook, New York, 11794

    Study Coordinator, 631-444-4392

    Recruiting

  • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)

    Thomasville, Georgia, 31792

    Completed

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)

    Tyler, Texas, 75701

    Study Coordinator, 903-595-7093

    Recruiting

Other trials in United States

Japan24 sites

  • Juntendo University Hospital ( Site 2468)

    Bunkyo, Tokyo, 113-8431

    Active, not recruiting

  • Fukushima Medical University Hospital ( Site 2461)

    Fukushima, 960-1295

    Active, not recruiting

  • Gifu University Hospital ( Site 2486)

    Gifu, 501-1194

    Active, not recruiting

  • Saitama Medical University International Medical Center ( Site 2462)

    Hidaka, Saitama, 350-1298

    Active, not recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2478)

    Hiroshima, 730-8518

    Active, not recruiting

  • Tokai University Hospital ( Site 2473)

    Isehara, Kanagawa, 259-1193

    Active, not recruiting

  • Social medical corporation Hakuaikai Sagara Hospital ( Site 2481)

    Kagoshima, 892-0833

    Active, not recruiting

  • National Cancer Center Hospital East ( Site 2463)

    Kashiwa, Chiba, 277-8577

    Active, not recruiting

  • St. Marianna University Hospital ( Site 2465)

    Kawasaki, Kanagawa, 216-8511

    Active, not recruiting

  • Cancer Institute Hospital of JFCR ( Site 2464)

    Koto, Tokyo, 135-8550

    Active, not recruiting

  • Kumamoto University Hospital ( Site 2480)

    Kumamoto, 860-8556

    Active, not recruiting

  • Kyoto University Hospital ( Site 2475)

    Kyoto, 606-8507

    Active, not recruiting

  • Nagoya City University Hospital ( Site 2474)

    Nagoya, Aichi-ken, 467-8602

    Active, not recruiting

  • Okayama University Hospital ( Site 2485)

    Okayama, 700-8558

    Active, not recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2477)

    Osaka, 541-8567

    Active, not recruiting

  • Kitasato University Hospital ( Site 2471)

    Sagamihara, Kanagawa, 252-0375

    Active, not recruiting

  • Hokkaido University Hospital ( Site 2460)

    Sapporo, Hokkaido, 060-8648

    Active, not recruiting

  • Tohoku University Hospital ( Site 2482)

    Sendai, Miyagi, 980-8574

    Active, not recruiting

  • Showa Medical University Hospital ( Site 2466)

    Shinagawa, Tokyo, 142-8666

    Active, not recruiting

  • Tokyo Medical University Hospital ( Site 2467)

    Shinjuku, Tokyo, 160-0023

    Active, not recruiting

  • National Center for Global Health and Medicine ( Site 2469)

    Shinjuku, Tokyo, 162-8655

    Active, not recruiting

  • The University of Osaka Hospital ( Site 2476)

    Suita, Osaka, 565-0871

    Active, not recruiting

  • Mie University Hospital ( Site 2483)

    Tsu, Mie-ken, 514-8507

    Active, not recruiting

  • Kanagawa Cancer Center ( Site 2472)

    Yokohama, Kanagawa, 241-8515

    Active, not recruiting

Other trials in Japan

Poland11 sites

  • Bialostockie Centrum Onkologii ( Site 1585)

    Bialystok, Podlaskie Voivodeship, 15-027

    Active, not recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1582)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Active, not recruiting

  • Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)

    Gdynia, Pomeranian Voivodeship, 81-519

    Active, not recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590)

    Gliwice, Silesian Voivodeship, 44-102

    Active, not recruiting

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Active, not recruiting

  • Szpital Wojewódzki w Koszalinie. ( Site 1583)

    Poland, West Pomeranian Voivodeship, 75-581

    Active, not recruiting

  • Mrukmed-Mrukmed ( Site 1592)

    Rzeszów, Podkarpackie Voivodeship, 35-021

    Active, not recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)

    Siedlce, Masovian Voivodeship, 08-110

    Active, not recruiting

  • Zachodniopomorskie Centrum Onkologii ( Site 1588)

    Szczecin, West Pomeranian Voivodeship, 71-730

    Completed

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580)

    Warsaw, Masovian Voivodeship, 02-781

    Active, not recruiting

  • Mazowiecki Szpital Onkologiczny ( Site 1581)

    Wieliszew, Masovian Voivodeship, 05-135

    Active, not recruiting

Other trials in Poland

Germany9 sites, 8 recruiting

  • Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314)

    Berlin, 13125

    Study Coordinator, +4930940113394

    Recruiting

  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311)

    Düsseldorf, North Rhine-Westphalia, 40225

    Study Coordinator, +492118117506

    Recruiting

  • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301)

    Erlangen, Bavaria, 91054

    Study Coordinator, +4991318533572

    Recruiting

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1300)

    Essen, North Rhine-Westphalia, 45136

    Study Coordinator, +4920117433001

    Recruiting

  • Franziskus-Hospital Harderberg ( Site 1308)

    Georgsmarienhütte, Lower Saxony, 49124

    Completed

  • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315)

    Gera, Thuringia, 07548

    Study Coordinator, +493658287758

    Recruiting

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1303)

    München, Bavaria, 80336

    Study Coordinator, +4989440034645

    Recruiting

  • Klinikum Ernst von Bergmann-Frauenklinik ( Site 1305)

    Potsdam, Brandenburg, 14467

    Study Coordinator, +493312415602

    Recruiting

  • CaritasKlinikum Saarbruecken St. Theresia ( Site 1304)

    Saarbrücken, Saarland, 66113

    Study Coordinator, +496814061345

    Recruiting

Other trials in Germany

Italy9 sites, 9 recruiting

  • CRO-IRCCS ( Site 1478)

    Aviano, Friuli Venezia Giulia, 33081

    Study Coordinator, +39 0434659514

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)

    Bologna, 40138

    Study Coordinator, +39 0512144548

    Recruiting

  • Ospedale San Martino ( Site 1479)

    Genova, 16132

    Study Coordinator, +390105600387

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480)

    Meldola, Forli-Cesena, 47014

    Study Coordinator, +390543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)

    Milan, Lombardy, 20133

    Study Coordinator, +390223902849

    Recruiting

  • Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)

    Milan, Lombardy, 20141

    Study Coordinator, +02 57489970

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 1471)

    Milan, 20132

    Study Coordinator, +390226436530

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)

    Roma, 00168

    Study Coordinator, +3930156318

    Recruiting

  • Istituto Clinico Humanitas ( Site 1476)

    Rozzano, Milano, 20089

    Study Coordinator, +390282244080

    Recruiting

Other trials in Italy

Turkey (Türkiye)8 sites, 7 recruiting

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876)

    Adana, 01140

    Study Coordinator, 905056166338

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870)

    Ankara, 06230

    Study Coordinator, +903123054330 (9264)

    Recruiting

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1874)

    Ankara, 06520

    Study Coordinator, 00905067521275

    Recruiting

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871)

    Ankara, 06800

    Study Coordinator, +903125526000/622111

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872)

    Istanbul, 34722

    Completed

  • Samsun Medical Park Hastanesi-medical oncology ( Site 1873)

    Samsun, 55200

    Study Coordinator, +90 362 311 40 40

    Recruiting

  • Medipol Mega Universite Hastanesi-oncology ( Site 1875)

    Stanbul, Istanbul, 34214

    Study Coordinator, 4447044

    Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878)

    Yenimahalle, Ankara, 06200

    Study Coordinator, 0090 506 366 5181

    Recruiting

Other trials in Turkey (Türkiye)

Canada7 sites, 6 recruiting

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)

    Montreal, Quebec, H1T 2M4

    Study Coordinator, 514-252-3400 x5370

    Recruiting

  • Jewish General Hospital ( Site 0303)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 514-340-8222

    Recruiting

  • Southlake Health ( Site 0311)

    Newmarket, Ontario, L3Y 2P9

    Completed

  • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)

    Québec, Quebec, G1S 4L8

    Study Coordinator, 418-682-7511

    Recruiting

  • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)

    Rimouski, Quebec, G5L 5T1

    Study Coordinator, 418 724-3000 x8029

    Recruiting

  • BC Cancer Surrey ( Site 0315)

    Surrey, British Columbia, V3V 1Z2

    Study Coordinator, 604-930-2098

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0310)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-946-5605

    Recruiting

Other trials in Canada

France7 sites, 7 recruiting

  • Centre François Baclesse ( Site 1250)

    Caen, Calvados, 14076

    Study Coordinator, +33231455050

    Recruiting

  • Hopital Prive Jean Mermoz-Oncology ( Site 1246)

    Lyon, Auvergne-Rhône-Alpes, 69008

    Study Coordinator, 33437538725

    Recruiting

  • Centre de Cancérologie du Grand Montpellier ( Site 1244)

    Montpellier, Languedoc-Roussillon, 34070

    Study Coordinator, 0430298723

    Recruiting

  • Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)

    Nantes, Loire-Atlantique, 44277

    Study Coordinator, 33228272088

    Recruiting

  • Pitie Salpetriere University Hospital ( Site 1249)

    Paris, 75013

    Study Coordinator, 33142160097

    Recruiting

  • Institut Curie-Oncology medical Department ( Site 1240)

    Paris, 75248

    Study Coordinator, +33144324675

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)

    Poitiers, Vienne, 86021

    Study Coordinator, 33549444548

    Recruiting

Other trials in France

Netherlands7 sites, 7 recruiting

  • Meander Medisch Centrum ( Site 1521)

    Amersfoort, Utrecht, 3813 TZ

    Study Coordinator, +31338507278

    Recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205129111

    Recruiting

  • Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)

    Arnhem, Gelderland, 6815 AD

    Study Coordinator, +31880056201

    Recruiting

  • Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)

    Breda, North Brabant, 4800 RK

    Study Coordinator, +31765952408

    Recruiting

  • Catharina Ziekenhuis ( Site 1526)

    Eindhoven, North Brabant, 5623 EJ

    Study Coordinator, +31402396622

    Recruiting

  • Maastricht UMC+-Medical Oncology ( Site 1522)

    Maastricht, Limburg, 6229 HX

    Study Coordinator, +31433877025

    Recruiting

  • Isala, locatie Zwolle ( Site 1525)

    Zwolle, Overijssel, 8025 AB

    Study Coordinator, +31886246040

    Recruiting

Other trials in Netherlands

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)

    Córdoba, 14004

    Study Coordinator, +34957511464

    Recruiting

  • Hospital Beata María Ana ( Site 1755)

    Madrid, Madrid, Comunidad de, 28007

    Study Coordinator, +34914097423

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)

    Madrid, 28009

    Study Coordinator, +3491 426 93 92

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)

    Pozuelo de Alarcón, Madrid, 28223

    Study Coordinator, +34914521987

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 1757)

    Seville, 41009

    Study Coordinator, +34955008000

    Recruiting

  • HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)

    Valencia, Valenciana, Comunitat, 46010

    Study Coordinator, +34961973583

    Recruiting

Other trials in Spain

Argentina6 sites, 4 recruiting

  • Instituto Alexander Fleming-Alexander Fleming ( Site 0382)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

    Active, not recruiting

  • Hospital Aleman-Oncology ( Site 0386)

    Buenos Aires, C1118AAT

    Study Coordinator, 541148277000 #3036

    Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)

    Buenos Aires, C1431FWO

    Study Coordinator, 52990100

    Recruiting

  • Hospital Italiano de Córdoba ( Site 0385)

    Córdoba, X5004BAL

    Study Coordinator, +543514106500

    Recruiting

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)

    La Rioja, F5300COE

    Study Coordinator, 543804436443 x108

    Recruiting

  • Fundacion Estudios Clinicos-Oncology ( Site 0384)

    Rosario, Santa Fe Province, S2000DEJ

    Active, not recruiting

Other trials in Argentina

Brazil6 sites, 6 recruiting

  • Hospital Moinhos de Vento ( Site 0403)

    Porto Alegre, Rio Grande do Sul, 90035-001

    Study Coordinator, +555133142965

    Recruiting

  • Hospital do Câncer Mãe de Deus ( Site 0404)

    Porto Alegre, Rio Grande do Sul, 90110-270

    Study Coordinator, +555133072943

    Recruiting

  • Instituto de Oncologia Saint Gallen ( Site 0412)

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

    Study Coordinator, +55513056-8686

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)

    São Paulo, 04014-012

    Study Coordinator, +551144500300

    Recruiting

  • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)

    Taubaté, São Paulo, 12030-200

    Study Coordinator, +551236318559

    Recruiting

  • Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)

    Teresina, Piauí, 64049-200

    Study Coordinator, +5586999007799

    Recruiting

Other trials in Brazil

Chile6 sites, 5 recruiting

  • Bradford Hill Norte ( Site 0456)

    Antofagasta, 1263521

    Study Coordinator, 56442023631

    Recruiting

  • FALP-UIDO ( Site 0451)

    Santiago, Region M. de Santiago, 7500921

    Active, not recruiting

  • Oncovida ( Site 0453)

    Santiago, Region M. de Santiago, 7500994

    Study Coordinator, 56226023875

    Recruiting

  • Clínica RedSalud Vitacura ( Site 0455)

    Santiago, Region M. de Santiago, 7650018

    Study Coordinator, 56223954044

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0454)

    Santiago, Region M. de Santiago, 832000

    Study Coordinator, +56934331806

    Recruiting

  • Bradfordhill ( Site 0452)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

Other trials in Chile

Greece6 sites, 6 recruiting

  • Errikos Dunant Hospital Center ( Site 1348)

    Athens, Attica, 115 26

    Study Coordinator, +302106972433

    Recruiting

  • Aretaieio Hospital Oncology Unit ( Site 1345)

    Athens, Attica, 115 28

    Study Coordinator, +302107286444

    Recruiting

  • University General Hospital of Larissa ( Site 1343)

    Larissa, Thessaly, 411 10

    Study Coordinator, +302413502785

    Recruiting

  • Hygeia Hospital ( Site 1346)

    Marousi, Attica, 151 23

    Study Coordinator, +302106867165

    Recruiting

  • European Interbalkan Medical Center ( Site 1341)

    Thessaloniki, 570 01

    Study Coordinator, +302313252011

    Recruiting

  • European Interbalkan Medical Center ( Site 1347)

    Thessaloniki, 570 01

    Study Coordinator, +302310390566

    Recruiting

Other trials in Greece

Hungary6 sites, 6 recruiting

  • Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381)

    Budapest, 1082

    Study Coordinator, 36208258821

    Recruiting

  • Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)

    Budapest, 1145

    Study Coordinator, +36209674709

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)

    Debrecen, 4032

    Study Coordinator, +3652255585

    Recruiting

  • Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)

    Kaposvár, Somogy County, 7400

    Study Coordinator, 36304111268

    Recruiting

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)

    Szeged, Csongrád megye, 6720

    Study Coordinator, 3662545404

    Recruiting

  • Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)

    Zalaegerszeg, Zala County, 8900

    Study Coordinator, 36304199969

    Recruiting

Other trials in Hungary

Mexico6 sites, 1 recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)

    Guadalajara, Jalisco, 44630

    Active, not recruiting

  • Grupo Médico ASSET-Clinical Research ( Site 0596)

    Mexico City, Mexico City, 03100

    Active, not recruiting

  • Health Pharma Professional Research S.A. de C.V: ( Site 0598)

    Mexico City, Mexico City, 03100

    Study Coordinator, +525575864856

    Recruiting

  • INCAN-TUMORES MAMARIOS ( Site 0597)

    Mexico City, Mexico City, 14080

    Completed

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590)

    Monterrey, Nuevo León, 64460

    Active, not recruiting

  • CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595)

    San Pedro Garza García, Nuevo León, 66278

    Active, not recruiting

Other trials in Mexico

Taiwan6 sites, 3 recruiting

  • Changhua Christian Hospital ( Site 2410)

    Changhua, 50006

    Completed

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413)

    Kaohsiung City, 83301

    Active, not recruiting

  • National Cheng Kung University Hospital-Surgery ( Site 2411)

    Tainan, 704

    Study Coordinator, +88662353535

    Recruiting

  • National Taiwan University Hospital-Oncology ( Site 2415)

    Taipei, 10002

    Study Coordinator, 886-2-23123456x71673

    Recruiting

  • Mackay Memorial Hospital ( Site 2412)

    Taipei, 10449

    Study Coordinator, +886225433535

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414)

    Taoyuan, 333

    Active, not recruiting

Other trials in Taiwan

United Kingdom6 sites, 6 recruiting

  • Blackpool Victoria Hospital ( Site 1941)

    Blackpool, FY3 8NR

    Study Coordinator, 01253 951524

    Recruiting

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)

    London, London, City of, EC1A 7BE

    Study Coordinator, 1-888-577-8839

    Recruiting

  • University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)

    London, London, City of, NW1 2PG

    Study Coordinator, 1-888-577-8839

    Recruiting

  • North West Cancer Centre ( Site 1944)

    Londonderry, Derry and Strabane, BT47 6SB

    Study Coordinator, 02871320781

    Recruiting

  • City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)

    Nottingham, NG5 1PB

    Study Coordinator, 441159691169

    Recruiting

  • The Royal Cornwall Hospital ( Site 1943)

    Truro, England, TR1 3LJ

    Study Coordinator, +441872258343

    Recruiting

Other trials in United Kingdom

Belgium5 sites, 5 recruiting

  • Institut Jules Bordet-Medicine Oncology ( Site 1104)

    Anderlecht, Bruxelles-Capitale, Region de, 1070

    Study Coordinator, +32 2 541 72 51

    Recruiting

  • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227645106

    Recruiting

  • AZ Maria Middelares-IKG ( Site 1106)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, 09 246 95 23

    Recruiting

  • Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)

    Hasselt, Limburg, 3500

    Study Coordinator, +3211337990

    Recruiting

  • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107)

    Namur, 5530

    Study Coordinator, 3281423849

    Recruiting

Other trials in Belgium

Colombia5 sites, 5 recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +57 6017454421x90614

    Recruiting

  • Fundación Valle del Lili ( Site 0508)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +576023319090 - 4022

    Recruiting

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)

    Medellín, Antioquia, 050030

    Study Coordinator, +57 3147362301

    Recruiting

  • IMAT S.A.S ( Site 0502)

    Montería, Departamento de Córdoba, 23002

    Study Coordinator, + 57 320 566 9416

    Recruiting

  • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)

    Valledupar, Cesar Department, 200001

    Study Coordinator, + 57 317 515 0103

    Recruiting

Other trials in Colombia

Czechia5 sites, 5 recruiting

  • Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138)

    České Budějovice, South Bohemian Region, 370 01

    Study Coordinator, +420387875001

    Recruiting

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132)

    Olomouc, Olomouc Region, 779 00

    Study Coordinator, +420588444295

    Recruiting

  • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 1134)

    Ostrava-Poruba, Moravian-Silesian Region, 708 52

    Study Coordinator, +420597372124

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady-Onkologická klinika ( Site 1135)

    Prague, 100 34

    Study Coordinator, +420267163562

    Recruiting

  • Fakultní nemocnice Motol a Homolka ( Site 1136)

    Prague, 150 06

    Study Coordinator, +420224431111

    Recruiting

Other trials in Czechia

Denmark5 sites, 4 recruiting

  • Rigshospitalet ( Site 1180)

    Copenhagen, Capital Region, 2100

    Study Coordinator, +45 35453545

    Recruiting

  • Nordsjællands Hospital - Hillerød ( Site 1184)

    Hillerød, Capital Region, 3400

    Study Coordinator, +4548294829

    Recruiting

  • Næstved Sygehus ( Site 1182)

    Næstved, Region Sjælland, 4700

    Completed

  • Odense Universitetshospital ( Site 1181)

    Odense C, Region Syddanmark, 5000

    Study Coordinator, +45 66113333

    Recruiting

  • Vejle Sygehus ( Site 1183)

    Vejle, Region Syddanmark, 7100

    Study Coordinator, +45 79405000

    Recruiting

Other trials in Denmark

South Africa5 sites, 5 recruiting

  • Cancercare Rondebosch Oncology-Clinical trials ( Site 2904)

    Cape Town, Western Cape, 7700

    Study Coordinator, +279443700

    Recruiting

  • Wits Clinical Research ( Site 2903)

    Johannesburg, Gauteng, 2196

    Study Coordinator, +27113390600

    Recruiting

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905)

    Port Elizabeth, Eastern Cape, 6055

    Study Coordinator, 041 450 6152

    Recruiting

  • Curo Oncology ( Site 2908)

    Pretoria, Gauteng, 0084

    Study Coordinator, +27123356771

    Recruiting

  • Sandton Oncology Medical Group (Pty) Ltd ( Site 2911)

    Sandton, Gauteng, 2196

    Study Coordinator, +27118830900

    Recruiting

Other trials in South Africa

Australia4 sites, 3 recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 2003)

    Frankston, Victoria, 3199

    Completed

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)

    Macquarie University, New South Wales, 2109

    Study Coordinator, +61298122956

    Recruiting

  • Fiona Stanley Hospital-Medical Oncology ( Site 2004)

    Murdoch, Western Australia, 6150

    Study Coordinator, +61861526530

    Recruiting

  • Westmead Hospital ( Site 2000)

    Westmead, New South Wales, 2145

    Study Coordinator, +61288905200

    Recruiting

Other trials in Australia

India4 sites, 3 recruiting

  • Tata Memorial Hospital-Medical Oncology ( Site 2053)

    Mumbai, Maharashtra, 400012

    Study Coordinator, 9967111418

    Recruiting

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056)

    Mumbai, Maharashtra, 400053

    Completed

  • All India Institute of Medical Sciences ( Site 2051)

    New Delhi, National Capital Territory of Delhi, 110029

    Study Coordinator, 504326588500

    Recruiting

  • Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052)

    New Delhi, National Capital Territory of Delhi, 110085

    Study Coordinator, 8005328138

    Recruiting

Other trials in India

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus-Oncology Division ( Site 1452)

    Haifa, 3109601

    Study Coordinator, 04-7776234

    Recruiting

  • Hadassah Medical Center ( Site 1451)

    Jerusalem, 9112001

    Study Coordinator, 02-6777111

    Recruiting

  • Rabin Medical Center ( Site 1453)

    Petah Tikva, 4941492

    Study Coordinator, 039378076

    Recruiting

  • Sheba Medical Center ( Site 1450)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

Other trials in Israel

Peru4 sites

  • Clinica Vallesur - AUNA ( Site 0652)

    Arequipa, Ariqipa, 15036

    Active, not recruiting

  • Hospital Militar Central Luis Arias Schereiber ( Site 0651)

    Jesús María, Lima, 18

    Active, not recruiting

  • Oncosalud ( Site 0650)

    Lima, Muni Metro de Lima, 15036

    Active, not recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)

    Lima, 15036

    Active, not recruiting

Other trials in Peru

Romania4 sites

  • Spitalul Clinic Filantropia ( Site 1703)

    Bucharest, Bucharest, 011171

    Active, not recruiting

  • Centrul Medical Neolife- Baneasa ( Site 1704)

    Bucharest, 077190

    Active, not recruiting

  • Institutul Oncologic Cluj ( Site 1701)

    Cluj-Napoca, 400015

    Active, not recruiting

  • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)

    Florești, Cluj, 407280

    Active, not recruiting

Other trials in Romania

South Korea4 sites

  • Seoul National University Hospital-Internal Medicine ( Site 2353)

    Seoul, 03080

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)

    Seoul, 03722

    Active, not recruiting

  • Asan Medical Center-Department of Oncology ( Site 2352)

    Seoul, 05505

    Active, not recruiting

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)

    Seoul, 06351

    Active, not recruiting

Other trials in South Korea

Costa Rica3 sites

  • CIMCA ( Site 0551)

    San José, Provincia de San José, 10103

    Active, not recruiting

  • ICIMED ( Site 0552)

    San José, 10108

    Active, not recruiting

  • Hospital Metropolitano - Sede Lindora ( Site 0550)

    Santa Ana, Provincia de San José, 10903

    Active, not recruiting

Other trials in Costa Rica

Ireland3 sites, 3 recruiting

  • Bon Secours Cork Hospital ( Site 1422)

    Cork, T12 DV56

    Study Coordinator, +353214542807

    Recruiting

  • St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420)

    Dublin, D04 T6F4

    Study Coordinator, +353012214000

    Recruiting

  • Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423)

    Dublin, D07 R2WY

    Study Coordinator, +353018034834

    Recruiting

Other trials in Ireland

Malaysia3 sites, 3 recruiting

  • Hospital Sultan Ismail ( Site 2153)

    Johor Bahru, Johor, 81100

    Study Coordinator, +6073565155

    Recruiting

  • Pantai Hospital Kuala Lumpur ( Site 2151)

    Kuala Lumpur, 59100

    Study Coordinator, +60327814519

    Recruiting

  • Sarawak General Hospital ( Site 2154)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276820

    Recruiting

Other trials in Malaysia

Portugal3 sites, 3 recruiting

  • Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)

    Lisbon, Lisbon District, 2720-276

    Study Coordinator, 00351214348200

    Recruiting

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661)

    Lisbon, 1649-035

    Study Coordinator, 00351217805000

    Recruiting

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662)

    Porto, 4200-072

    Study Coordinator, 00351225084000

    Recruiting

Other trials in Portugal

Sweden3 sites, 3 recruiting

  • Södra Älvsborgs Sjukhus Borås ( Site 1803)

    Borås, Västra Götaland County, 501 82

    Study Coordinator, +46336161000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 1801)

    Stockholm, Stockholm County, 171 76

    Study Coordinator, +46812370000

    Recruiting

  • Akademiska sjukhuset ( Site 1802)

    Uppsala, Uppsala County, 75185

    Study Coordinator, +46186110000

    Recruiting

Other trials in Sweden

Switzerland3 sites, 3 recruiting

  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)

    Basel, Canton of Basel-City, 4031

    Study Coordinator, +41613284214

    Recruiting

  • Spital Thun ( Site 1840)

    Thun, Canton of Bern, 3600

    Study Coordinator, +41 58 636 22 27

    Recruiting

  • Brust-Zentrum ( Site 1841)

    Zurich, Canton of Zurich, 8008

    Study Coordinator, +41 44 533 81 05

    Recruiting

Other trials in Switzerland

Hong Kong2 sites, 2 recruiting

  • Queen Mary Hospital ( Site 2040)

    Hksar

    Study Coordinator, QMH- +852 2255 3838

    Recruiting

  • Prince of Wales Hospital ( Site 2041)

    Shatin

    Study Coordinator, +852 3505 2211

    Recruiting

Other trials in Hong Kong

Philippines2 sites, 2 recruiting

  • Metro Davao Medical and Research Center ( Site 2202)

    Davao City, Davao Del Sur, 8000

    Study Coordinator, (082) - 287-7777

    Recruiting

  • ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200)

    Quezon City, National Capital Region, 1102

    Study Coordinator, 09498889607

    Recruiting

Other trials in Philippines

Puerto Rico2 sites, 1 recruiting

  • Puerto Rico Medical Research Center LLC ( Site 0675)

    Hato Rey, 00917

    Completed

  • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)

    San Juan, 00935

    Study Coordinator, 7877728300 Ext 1226

    Recruiting

Other trials in Puerto Rico

Singapore2 sites, 2 recruiting

  • National University Hospital ( Site 2250)

    Singapore, Central Singapore, 119074

    Study Coordinator, +6569082222

    Recruiting

  • Mount Alvernia ICON Cancer Center ( Site 2251)

    Singapore, North East, 574623

    Study Coordinator, +6562550528

    Recruiting

Other trials in Singapore

New Zealand1 site

  • Auckland City Hospital ( Site 2031)

    Auckland, 1023

    Active, not recruiting

Other trials in New Zealand

About this study

Official title: 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.

Being tested
Sacituzumab tirumotecan, Pembrolizumab, Paclitaxel, Nab-paclitaxel, Capecitabine
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Breast Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanDrug

    Also called MK-2870

    IV infusion

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • PaclitaxelDrug

    Also called TAXOL®

    IV infusion

  • Nab-paclitaxelDrug

    Also called ABRAXANE®

    IV infusion

  • CapecitabineDrug

    Also called XELODA®

    oral tablet

  • Liposomal doxorubicinDrug

    Also called DOXIL®

    IV infusion

Study groups in NCT06312176
Study groupRoleWhat they receive
Arm A: Sacituzumab tirumotecanExperimentalParticipants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Receives: Drug: Sacituzumab tirumotecan
Arm B:Pembrolizumab + Sacituzumab tirumotecanExperimentalParticipants 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).
Receives: Drug: Sacituzumab tirumotecan; Biological: Pembrolizumab
Arm C: Treatment of Physician's Choice (TPC)Active comparatorAt 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.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Capecitabine; Drug: Liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)

    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.

    Measured: Up to ~40 months

  2. PFS (Sacituzumab tirumotecan + pembrolizumab versus TPC)

    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 BICR in participants with programmed cell death ligand 1 (PD-L1) at combined positive score (CPS) ≥1 tumors will be presented.

    Measured: Up to ~40 months

Secondary outcomes (16)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~95 months

  2. Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)

    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.

    Measured: Up to ~57 months

  3. Objective Response Rate (ORR)

    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.

    Measured: Up to ~95 months

  4. Duration of Response (DOR)

    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.

    Measured: Up to ~95 months

  5. 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)

    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.

    Measured: Baseline and up to ~95 months

  6. Change from baseline in physical functioning score, on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to ~95 months

  7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to ~95 months

  8. Change from baseline in fatigue score, on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to ~95 months

  9. Change from baseline in diarrhea score, on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to ~95 months

  10. Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30

    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.

    Measured: Up to ~95 months

  11. TTD in physical functioning score, on the EORTC QLQ-C30

    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.

    Measured: Up to ~95 months

  12. TTD in emotional functioning score, on the EORTC QLQ-C30

    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.

    Measured: Up to ~95 months

  13. TTD in fatigue score, on the EORTC QLQ-C30

    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.

    Measured: Up to ~95 months

  14. TTD in diarrhea score, on the EORTC QLQ-C30

    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.

    Measured: Up to ~95 months

  15. Number of participants who experience one or more adverse events (AEs)

    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.

    Measured: Up to ~95 months

  16. Number of participants who discontinue study treatment due to an AE

    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.

    Measured: Up to ~95 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start14 Apr 2024
  3. Primary completion11 Jul 2027 (estimated)
  4. Study completion12 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312176
Sponsor's protocol ID
2870-010
Other IDs
MK-2870-010, 2023-504918-29-00, U1111-1289-8119, jRCT2031240476, 2023
Status last verified
Oct 2026
First submitted
7 Mar 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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