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NCT06312176

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)

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-14

Study Completion Date

2031-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type DRUG

IV infusion

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).

Group Type EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type DRUG

IV infusion

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

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.

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

IV infusion

Nab-paclitaxel

Intervention Type DRUG

IV infusion

Capecitabine

Intervention Type DRUG

oral tablet

Liposomal doxorubicin

Intervention Type DRUG

IV infusion

Interventions

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Sacituzumab tirumotecan

IV infusion

Intervention Type DRUG

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Paclitaxel

IV infusion

Intervention Type DRUG

Nab-paclitaxel

IV infusion

Intervention Type DRUG

Capecitabine

oral tablet

Intervention Type DRUG

Liposomal doxorubicin

IV infusion

Intervention Type DRUG

Other Intervention Names

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MK-2870 MK-3475 KEYTRUDA® TAXOL® ABRAXANE® XELODA® DOXIL®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Ironwood Cancer & Research Centers ( Site 0066)

Chandler, Arizona, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center-Oncology ( Site 0004)

Gilbert, Arizona, United States

Site Status RECRUITING

Providence Medical Foundation-Oncology ( Site 0020)

Fullerton, California, United States

Site Status RECRUITING

Moores Cancer Center ( Site 0059)

La Jolla, California, United States

Site Status RECRUITING

Cancer and Blood Specialty Clinic ( Site 0001)

Los Alamitos, California, United States

Site Status RECRUITING

University of Colorado Anschutz Medical Campus ( Site 0061)

Aurora, Colorado, United States

Site Status RECRUITING

UCHealth Cherry Creek Medical Center ( Site 0094)

Denver, Colorado, United States

Site Status RECRUITING

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

Highlands Ranch, Colorado, United States

Site Status RECRUITING

Yale Cancer Center ( Site 0060)

New Haven, Connecticut, United States

Site Status RECRUITING

Stamford Hospital ( Site 0049)

Stamford, Connecticut, United States

Site Status RECRUITING

AdventHealth Altamonte Springs ( Site 0021)

Altamonte Springs, Florida, United States

Site Status RECRUITING

University of Florida College of Medicine ( Site 0063)

Gainesville, Florida, United States

Site Status RECRUITING

Orlando Health Cancer Institute ( Site 0011)

Orlando, Florida, United States

Site Status RECRUITING

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

Thomasville, Georgia, United States

Site Status RECRUITING

University of Chicago Medical Center ( Site 0067)

Chicago, Illinois, United States

Site Status RECRUITING

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

Edgewood, Kentucky, United States

Site Status RECRUITING

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

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Greenebaum Comprehensive Cancer Center ( Site 0036)

Baltimore, Maryland, United States

Site Status RECRUITING

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

Baltimore, Maryland, United States

Site Status COMPLETED

Holy Cross Hospital ( Site 0073)

Silver Spring, Maryland, United States

Site Status RECRUITING

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

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Health ( Site 0002)

Detroit, Michigan, United States

Site Status RECRUITING

Saint Luke's Cancer Institute ( Site 0027)

Kansas City, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine ( Site 0076)

St Louis, Missouri, United States

Site Status RECRUITING

NYU Langone Health - Brooklyn ( Site 0089)

Brooklyn, New York, United States

Site Status RECRUITING

NYU Langone Hospital - Long Island ( Site 0090)

Mineola, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

Hematology Oncology Associates of Rockland ( Site 0054)

Nyack, New York, United States

Site Status RECRUITING

Stony Brook University-Cancer Center ( Site 0034)

Stony Brook, New York, United States

Site Status RECRUITING

Levine Cancer Institute ( Site 0014)

Charlotte, North Carolina, United States

Site Status RECRUITING

Zangmeister Cancer Center ( Site 7000)

Columbus, Ohio, United States

Site Status RECRUITING

Providence Portland Medical Center ( Site 0044)

Portland, Oregon, United States

Site Status RECRUITING

Providence St. Vincent Medical Center ( Site 0081)

Portland, Oregon, United States

Site Status RECRUITING

Thomas Jefferson University - Clinical Research Institute ( Site 0056)

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern Medical Center ( Site 0050)

Dallas, Texas, United States

Site Status RECRUITING

The Center for Cancer and Blood Disorders ( Site 0041)

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Oncology - San Antonio ( Site 8002)

San Antonio, Texas, United States

Site Status RECRUITING

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

Tyler, Texas, United States

Site Status RECRUITING

Inova Schar Cancer Institute ( Site 0025)

Fairfax, Virginia, United States

Site Status RECRUITING

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

Midlothian, Virginia, United States

Site Status RECRUITING

VCU Health Adult Outpatient Pavillion ( Site 0070)

Richmond, Virginia, United States

Site Status RECRUITING

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

Roanoke, Virginia, United States

Site Status RECRUITING

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

Madison, Wisconsin, United States

Site Status RECRUITING

Instituto Alexander Fleming-Alexander Fleming ( Site 0382)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Fundacion Estudios Clinicos-Oncology ( Site 0384)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Hospital Aleman-Oncology ( Site 0386)

Buenos Aires, , Argentina

Site Status RECRUITING

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

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Italiano de Córdoba ( Site 0385)

Córdoba, , Argentina

Site Status RECRUITING

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

La Rioja, , Argentina

Site Status RECRUITING

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

Macquarie University, New South Wales, Australia

Site Status RECRUITING

Westmead Hospital ( Site 2000)

Westmead, New South Wales, Australia

Site Status RECRUITING

Frankston Hospital-Oncology and Haematology ( Site 2003)

Frankston, Victoria, Australia

Site Status COMPLETED

Fiona Stanley Hospital-Medical Oncology ( Site 2004)

Murdoch, Western Australia, Australia

Site Status RECRUITING

Institut Jules Bordet-Medicine Oncology ( Site 1104)

Anderlecht, Bruxelles-Capitale, Region de, Belgium

Site Status RECRUITING

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

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status RECRUITING

Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)

Hasselt, Limburg, Belgium

Site Status RECRUITING

AZ Maria Middelares-IKG ( Site 1106)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

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

Namur, , Belgium

Site Status RECRUITING

Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)

Teresina, Piauí, Brazil

Site Status RECRUITING

Hospital Moinhos de Vento ( Site 0403)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital do Câncer Mãe de Deus ( Site 0404)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Instituto de Oncologia Saint Gallen ( Site 0412)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Site Status RECRUITING

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)

Taubaté, São Paulo, Brazil

Site Status RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)

São Paulo, , Brazil

Site Status RECRUITING

BC Cancer Surrey ( Site 0315)

Surrey, British Columbia, Canada

Site Status RECRUITING

Southlake Regional Health Centre ( Site 0311)

Newmarket, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre ( Site 0310)

Toronto, Ontario, Canada

Site Status RECRUITING

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

Montreal, Quebec, Canada

Site Status RECRUITING

Jewish General Hospital ( Site 0303)

Montreal, Quebec, Canada

Site Status RECRUITING

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

Québec, Quebec, Canada

Site Status RECRUITING