NCT06841354From ClinicalTrials.govRecruiting

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Triple Negative Breast Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Merck Sharp & Dohme LLC
Enrolment target: 1,000
Started: 16 March 2025
Main results due: 18 May 2030
Study sites: 281
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:

The main inclusion criteria include but are not limited to the following:

* Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
* Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
* Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
* Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has breast cancer amenable to treatment with curative intent
* Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
* Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
* Has Grade ≥2 peripheral neuropathy
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has skin only metastatic disease
* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
* History of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

What this study is about

In the sponsor’s own words, from the registry.

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Study sites(281)

USA Mitchell Cancer Institute ( Site 0090)
Mobile, Alabama, United States
Recruiting
Ironwood Cancer & Research Centers ( Site 0036)
Chandler, Arizona, United States
Recruiting
City of Hope ( Site 0097)
Duarte, California, United States
Recruiting
City of Hope Lennar Foundation Cancer Center ( Site 0099)
Irvine, California, United States
Recruiting
UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
Los Angeles, California, United States
Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
San Francisco, California, United States
Recruiting
Yale New Haven Hospital ( Site 0001)
New Haven, Connecticut, United States
Completed
Washington Hospital Center ( Site 0098)
Washington D.C., District of Columbia, United States
Recruiting
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)
Altamonte Springs, Florida, United States
Recruiting
Orlando Health Cancer Institute ( Site 0012)
Orlando, Florida, United States
Recruiting
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
Recruiting
University Cancer & Blood Center, LLC ( Site 0023)
Athens, Georgia, United States
Recruiting
St. Luke's Cancer Institute: Boise ( Site 0037)
Boise, Idaho, United States
Recruiting
University of Illinois Cancer Center ( Site 0044)
Chicago, Illinois, United States
Recruiting
MedStar Franklin Square Medical Center ( Site 0031)
Baltimore, Maryland, United States
Recruiting
MedStar Good Samaritan Hospital ( Site 0079)
Baltimore, Maryland, United States
Recruiting
MedStar Southern Maryland Hospital Center ( Site 0100)
Clinton, Maryland, United States
Recruiting
MedStar Montgomery Medical Center ( Site 0078)
Olney, Maryland, United States
Recruiting
Holy Cross Hospital ( Site 0091)
Silver Spring, Maryland, United States
Recruiting
Cancer & Hematology Centers of Western Michigan ( Site 0026)
Grand Rapids, Michigan, United States
Recruiting
Allina Health Cancer Institute ( Site 0069)
Minneapolis, Minnesota, United States
Recruiting
Hattiesburg Clinic Hematology/Oncology ( Site 0104)
Hattiesburg, Mississippi, United States
Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0015)
Las Vegas, Nevada, United States
Recruiting
Renown Regional Medical Center ( Site 0005)
Reno, Nevada, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)
Hackensack, New Jersey, United States
Recruiting
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
Albuquerque, New Mexico, United States
Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)
Mineola, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0003)
New York, New York, United States
Recruiting
Rex Hematology Oncology Associates - Garner ( Site 0071)
Garner, North Carolina, United States
Completed
SCRI Oncology Partners ( Site 7004)
Nashville, Tennessee, United States
Recruiting
Tennessee Oncology ( Site 0018)
Nashville, Tennessee, United States
Recruiting
Texas Oncology - DFW ( Site 8007)
Dallas, Texas, United States
Recruiting
Texas Oncology - West Texas ( Site 8004)
El Paso, Texas, United States
Recruiting
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)
Houston, Texas, United States
Recruiting
Kelsey-Seybold Clinic ( Site 0040)
Houston, Texas, United States
Recruiting
Texas Oncology - San Antonio ( Site 8001)
San Antonio, Texas, United States
Recruiting
University of Utah, Huntsman Cancer Institute ( Site 0056)
Salt Lake City, Utah, United States
Recruiting
Virginia Oncology Associates (VOA) ( Site 8002)
Norfolk, Virginia, United States
Recruiting
Fred Hutchinson Cancer Center ( Site 0042)
Seattle, Washington, United States
Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)
Mar del Plata, Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming ( Site 2402)
Mar del Plata, Buenos Aires, Argentina
Recruiting
Hospital Italiano de Cordoba ( Site 2406)
Córdoba, Córdoba Province, Argentina
Recruiting
Clinica Viedma ( Site 2403)
Viedma, Río Negro Province, Argentina
Recruiting
Fundacion Estudios Clinicos ( Site 2405)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Provincial del Centenario ( Site 2410)
Rosario, Santa Fe Province, Argentina
Recruiting
Fundacion Centro Oncologico de Integración Regional ( Site 2400)
Mendoza, Argentina
Recruiting
Blacktown Hospital ( Site 5500)
Blacktown, New South Wales, Australia
Recruiting
Peninsula Health Frankston Hospital ( Site 5501)
Frankston, Victoria, Australia
Recruiting
ZAS Sint Augustinus ( Site 3102)
Antwerp, Flanders, Belgium
Recruiting
Ziekenhuis Oost Limburg ( Site 3105)
Genk, Limburg, Belgium
Recruiting
AZ Maria Middelares ( Site 3103)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
UZ Gent ( Site 3101)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
Hospital de Câncer de Recife ( Site 2300)
Recife, Pernambuco, Brazil
Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 2310)
Natal, Rio Grande do Norte, Brazil
Recruiting
Hospital Nossa Senhora da Conceição ( Site 2302)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)
Barretos, São Paulo, Brazil
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)
São Jose Do Rio Preto, São Paulo, Brazil
Recruiting
IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)
São Paulo, Brazil
Recruiting
Cross Cancer Institute ( Site 0216)
Edmonton, Alberta, Canada
Recruiting
Lakeridge Health ( Site 0217)
Oshawa, Ontario, Canada
Recruiting

Showing 60 of 281 sites — filter to narrow it down. 274 of the 281 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 NCT06841354. 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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