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)
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
- Breast Neoplasms
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 1,200
- Started
- 14 April 2024
- Main results due
- 11 July 2027
- Study sites
- 259
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(259)
Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona, United States
Recruiting
Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California, United States
Recruiting
Moores Cancer Center ( Site 0059)
La Jolla, California, United States
Active, not recruiting
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California, United States
Active, not recruiting
University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado, United States
Recruiting
UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado, United States
Recruiting
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
Highlands Ranch, Colorado, United States
Completed
Yale Cancer Center ( Site 0060)
New Haven, Connecticut, United States
Recruiting
Stamford Hospital ( Site 0049)
Stamford, Connecticut, United States
Recruiting
AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida, United States
Recruiting
University of Florida College of Medicine ( Site 0063)
Gainesville, Florida, United States
Active, not recruiting
Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida, United States
Recruiting
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia, United States
Recruiting
Rush University Medical Center ( Site 0079)
Chicago, Illinois, United States
Recruiting
University of Chicago Medical Center ( Site 0067)
Chicago, Illinois, United States
Active, not recruiting
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana, United States
Recruiting
Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland, United States
Recruiting
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
Baltimore, Maryland, United States
Completed
Holy Cross Hospital ( Site 0073)
Silver Spring, Maryland, United States
Recruiting
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
Boston, Massachusetts, United States
Recruiting
Henry Ford Health ( Site 0002)
Detroit, Michigan, United States
Recruiting
Saint Luke's Cancer Institute ( Site 0027)
Kansas City, Missouri, United States
Recruiting
Washington University School of Medicine ( Site 0076)
St Louis, Missouri, United States
Recruiting
NYU Langone Health - Brooklyn ( Site 0089)
Brooklyn, New York, United States
Recruiting
NYU Langone Hospital - Long Island ( Site 0090)
Mineola, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
New York, New York, United States
Recruiting
Hematology Oncology Associates of Rockland ( Site 0054)
Nyack, New York, United States
Recruiting
Stony Brook University-Cancer Center ( Site 0034)
Stony Brook, New York, United States
Recruiting
Levine Cancer Institute ( Site 0014)
Charlotte, North Carolina, United States
Recruiting
Zangmeister Cancer Center ( Site 7000)
Columbus, Ohio, United States
Completed
Providence Portland Medical Center ( Site 0044)
Portland, Oregon, United States
Recruiting
Providence St. Vincent Medical Center ( Site 0081)
Portland, Oregon, United States
Recruiting
Thomas Jefferson University - Clinical Research Institute ( Site 0056)
Philadelphia, Pennsylvania, United States
Recruiting
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
Dallas, Texas, United States
Recruiting
Parkland Health and Hospital System ( Site 0069)
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center ( Site 0050)
Dallas, Texas, United States
Recruiting
The Center for Cancer and Blood Disorders ( Site 0041)
Fort Worth, Texas, United States
Recruiting
Texas Oncology - San Antonio ( Site 8002)
San Antonio, Texas, United States
Recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
Tyler, Texas, United States
Recruiting
Inova Schar Cancer Institute ( Site 0025)
Fairfax, Virginia, United States
Recruiting
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
Midlothian, Virginia, United States
Recruiting
VCU Health Adult Outpatient Pavillion ( Site 0070)
Richmond, Virginia, United States
Recruiting
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
Roanoke, Virginia, United States
Recruiting
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
Madison, Wisconsin, United States
Recruiting
Instituto Alexander Fleming-Alexander Fleming ( Site 0382)
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Fundacion Estudios Clinicos-Oncology ( Site 0384)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Aleman-Oncology ( Site 0386)
Buenos Aires, Argentina
Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)
Buenos Aires, Argentina
Recruiting
Hospital Italiano de Córdoba ( Site 0385)
Córdoba, Argentina
Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)
La Rioja, Argentina
Recruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)
Macquarie University, New South Wales, Australia
Recruiting
Westmead Hospital ( Site 2000)
Westmead, New South Wales, Australia
Recruiting
Frankston Hospital-Oncology and Haematology ( Site 2003)
Frankston, Victoria, Australia
Completed
Fiona Stanley Hospital-Medical Oncology ( Site 2004)
Murdoch, Western Australia, Australia
Recruiting
Institut Jules Bordet-Medicine Oncology ( Site 1104)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
Recruiting
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)
Brussels, Bruxelles-Capitale, Region de, Belgium
Recruiting
Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)
Hasselt, Limburg, Belgium
Recruiting
AZ Maria Middelares-IKG ( Site 1106)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
Showing 60 of 259 sites — filter to narrow it down. 221 of the 259 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06312176. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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