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)
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.
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
Conditions
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
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06841354 live on ClinicalTrials.gov.