ClinicalTrials.gov record
Recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT06841354

Public ClinicalTrials.gov record NCT06841354. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 5:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT06841354
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
1,000 participants

Conditions and interventions

Interventions

  • Carboplatin Drug
  • Gemcitabine Drug
  • Nab-paclitaxel Drug
  • Paclitaxel Drug
  • Pembrolizumab Biological
  • Rescue Medication Drug
  • Sacituzumab tirumotecan Biological

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 15, 2025
Primary completion
May 17, 2030
Completion
May 17, 2030
Last update posted
May 5, 2026

2025 – 2030

United States locations

U.S. sites
37
U.S. states
22
U.S. cities
34
Facility City State ZIP Site status
USA Mitchell Cancer Institute ( Site 0090) Mobile Alabama 36604 Recruiting
Ironwood Cancer & Research Centers ( Site 0036) Chandler Arizona 85224 Recruiting
City of Hope ( Site 0097) Duarte California 91010 Recruiting
City of Hope Lennar Foundation Cancer Center ( Site 0099) Irvine California 92618 Recruiting
UCLA Department of Medicine - Hematology & Oncology ( Site 0047) Los Angeles California 90095 Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016) San Francisco California 94158 Recruiting
Yale New Haven Hospital ( Site 0001) New Haven Connecticut 06520 Recruiting
Washington Hospital Center ( Site 0098) Washington D.C. District of Columbia 20010-2975 Recruiting
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007) Altamonte Springs Florida 32701 Recruiting
Florida Cancer Specialists - East ( Site 7000) West Palm Beach Florida 33401 Recruiting
University Cancer & Blood Center, LLC ( Site 0023) Athens Georgia 30607 Recruiting
St. Luke's Cancer Institute: Boise ( Site 0037) Boise Idaho 83712 Recruiting
University of Illinois Cancer Center ( Site 0044) Chicago Illinois 60612 Recruiting
MedStar Franklin Square Medical Center ( Site 0031) Baltimore Maryland 21237 Recruiting
MedStar Good Samaritan Hospital ( Site 0079) Baltimore Maryland 21239 Recruiting
MedStar Southern Maryland Hospital Center ( Site 0100) Clinton Maryland 20735 Recruiting
MedStar Montgomery Medical Center ( Site 0078) Olney Maryland 20832 Recruiting
Holy Cross Hospital ( Site 0091) Silver Spring Maryland 20910 Recruiting
Cancer & Hematology Centers of Western Michigan ( Site 0026) Grand Rapids Michigan 49503 Recruiting
Allina Health Cancer Institute ( Site 0069) Minneapolis Minnesota 55407 Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0015) Las Vegas Nevada 89169 Recruiting
Renown Regional Medical Center ( Site 0005) Reno Nevada 89502 Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082) Hackensack New Jersey 07601 Recruiting
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019) Albuquerque New Mexico 87109 Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073) Mineola New York 11501 Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0003) New York New York 10016 Recruiting
UNC REX Cancer Center ( Site 0071) Raleigh North Carolina 27607 Recruiting
SCRI Oncology Partners ( Site 7004) Nashville Tennessee 37203 Recruiting
Tennessee Oncology ( Site 0018) Nashville Tennessee 37203 Recruiting
Texas Oncology - DFW ( Site 8007) Dallas Texas 75231 Recruiting
Texas Oncology - West Texas ( Site 8004) El Paso Texas 79902 Recruiting
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096) Houston Texas 77014 Recruiting
Kelsey-Seybold Clinic ( Site 0040) Houston Texas 77025 Recruiting
Texas Oncology - San Antonio ( Site 8001) San Antonio Texas 78240 Recruiting
University of Utah, Huntsman Cancer Institute ( Site 0056) Salt Lake City Utah 84112 Recruiting
Virginia Oncology Associates (VOA) ( Site 8002) Norfolk Virginia 23502 Recruiting
Fred Hutchinson Cancer Center ( Site 0042) Seattle Washington 98109 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 221 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06841354, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced May 8, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06841354 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →