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RECRUITING

NCT06312176

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2024-04-14

Completion Date

2031-04-12

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Breast Neoplasms

Interventions

DRUG

Sacituzumab tirumotecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Capecitabine

oral tablet

DRUG

Liposomal doxorubicin

IV infusion

Locations (259)

Ironwood Cancer & Research Centers ( Site 0066)

Chandler, Arizona, United States

Banner MD Anderson Cancer Center-Oncology ( Site 0004)

Gilbert, Arizona, United States

Providence Medical Foundation-Oncology ( Site 0020)

Fullerton, California, United States

Moores Cancer Center ( Site 0059)

La Jolla, California, United States

Cancer and Blood Specialty Clinic ( Site 0001)

Los Alamitos, California, United States

University of Colorado Anschutz Medical Campus ( Site 0061)

Aurora, Colorado, United States

UCHealth Cherry Creek Medical Center ( Site 0094)

Denver, Colorado, United States

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

Highlands Ranch, Colorado, United States

Yale Cancer Center ( Site 0060)

New Haven, Connecticut, United States

Stamford Hospital ( Site 0049)

Stamford, Connecticut, United States

AdventHealth Altamonte Springs ( Site 0021)

Altamonte Springs, Florida, United States

University of Florida College of Medicine ( Site 0063)

Gainesville, Florida, United States

Orlando Health Cancer Institute ( Site 0011)

Orlando, Florida, United States

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

Thomasville, Georgia, United States

Rush University Medical Center ( Site 0079)

Chicago, Illinois, United States

University of Chicago Medical Center ( Site 0067)

Chicago, Illinois, United States

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

Edgewood, Kentucky, United States

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

Baton Rouge, Louisiana, United States

Greenebaum Comprehensive Cancer Center ( Site 0036)

Baltimore, Maryland, United States

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

Baltimore, Maryland, United States

Holy Cross Hospital ( Site 0073)

Silver Spring, Maryland, United States

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

Boston, Massachusetts, United States

Henry Ford Health ( Site 0002)

Detroit, Michigan, United States

Saint Luke's Cancer Institute ( Site 0027)

Kansas City, Missouri, United States

Washington University School of Medicine ( Site 0076)

St Louis, Missouri, United States

NYU Langone Health - Brooklyn ( Site 0089)

Brooklyn, New York, United States

NYU Langone Hospital - Long Island ( Site 0090)

Mineola, New York, United States

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

New York, New York, United States

Hematology Oncology Associates of Rockland ( Site 0054)

Nyack, New York, United States

Stony Brook University-Cancer Center ( Site 0034)

Stony Brook, New York, United States

Levine Cancer Institute ( Site 0014)

Charlotte, North Carolina, United States

Zangmeister Cancer Center ( Site 7000)

Columbus, Ohio, United States

Providence Portland Medical Center ( Site 0044)

Portland, Oregon, United States

Providence St. Vincent Medical Center ( Site 0081)

Portland, Oregon, United States

Thomas Jefferson University - Clinical Research Institute ( Site 0056)

Philadelphia, Pennsylvania, United States

Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)

Dallas, Texas, United States

Parkland Health and Hospital System ( Site 0069)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0050)

Dallas, Texas, United States

The Center for Cancer and Blood Disorders ( Site 0041)

Fort Worth, Texas, United States

Texas Oncology - San Antonio ( Site 8002)

San Antonio, Texas, United States

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

Tyler, Texas, United States

Inova Schar Cancer Institute ( Site 0025)

Fairfax, Virginia, United States

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

Midlothian, Virginia, United States

VCU Health Adult Outpatient Pavillion ( Site 0070)

Richmond, Virginia, United States

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

Roanoke, Virginia, United States

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

Madison, Wisconsin, United States

Instituto Alexander Fleming-Alexander Fleming ( Site 0382)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos-Oncology ( Site 0384)

Rosario, Santa Fe Province, Argentina

Hospital Aleman-Oncology ( Site 0386)

Buenos Aires, Argentina

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

Buenos Aires, Argentina

Hospital Italiano de Córdoba ( Site 0385)

Córdoba, Argentina

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

La Rioja, Argentina

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

Macquarie University, New South Wales, Australia

Westmead Hospital ( Site 2000)

Westmead, New South Wales, Australia

Frankston Hospital-Oncology and Haematology ( Site 2003)

Frankston, Victoria, Australia

Fiona Stanley Hospital-Medical Oncology ( Site 2004)

Murdoch, Western Australia, Australia

Institut Jules Bordet-Medicine Oncology ( Site 1104)

Anderlecht, Bruxelles-Capitale, Region de, Belgium

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

Brussels, Bruxelles-Capitale, Region de, Belgium

Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)

Hasselt, Limburg, Belgium

AZ Maria Middelares-IKG ( Site 1106)

Ghent, Oost-Vlaanderen, Belgium

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

Namur, Belgium

Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)

Teresina, Piauí, Brazil

Hospital Moinhos de Vento ( Site 0403)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital do Câncer Mãe de Deus ( Site 0404)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0412)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)

Taubaté, São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)

São Paulo, Brazil

BC Cancer Surrey ( Site 0315)

Surrey, British Columbia, Canada

Southlake Health ( Site 0311)

Newmarket, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0310)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0303)

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

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

Rimouski, Quebec, Canada

FALP-UIDO ( Site 0451)