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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,000 · Started: Mar 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06841354

Locations in the U.S.

AlabamaUSA Mitchell Cancer Institute ( Site 0090), Mobile
ArizonaIronwood Cancer & Research Centers ( Site 0036), Chandler
CaliforniaCity of Hope ( Site 0097), Duarte
City of Hope Lennar Foundation Cancer Center ( Site 0099), Irvine
UCLA Department of Medicine - Hematology & Oncology ( Site 0047), Los Angeles
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016), San Francisco
District of ColumbiaWashington Hospital Center ( Site 0098), Washington D.C.
FloridaAdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007), Altamonte Springs
Orlando Health Cancer Institute ( Site 0012), Orlando
Florida Cancer Specialists - East ( Site 7000), West Palm Beach
GeorgiaUniversity Cancer & Blood Center, LLC ( Site 0023), Athens
IdahoSt. Luke's Cancer Institute: Boise ( Site 0037), Boise
IllinoisUniversity of Illinois Cancer Center ( Site 0044), Chicago
MarylandMedStar Franklin Square Medical Center ( Site 0031), Baltimore
MedStar Good Samaritan Hospital ( Site 0079), Baltimore
MedStar Southern Maryland Hospital Center ( Site 0100), Clinton
MedStar Montgomery Medical Center ( Site 0078), Olney
Holy Cross Hospital ( Site 0091), Silver Spring
MichiganCancer & Hematology Centers of Western Michigan ( Site 0026), Grand Rapids
MinnesotaAllina Health Cancer Institute ( Site 0069), Minneapolis
MississippiHattiesburg Clinic Hematology/Oncology ( Site 0104), Hattiesburg
NevadaComprehensive Cancer Centers of Nevada ( Site 0015), Las Vegas
Renown Regional Medical Center ( Site 0005), Reno
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0082), Hackensack
New MexicoNew Mexico Oncology Hematology Consultants Ltd. ( Site 0019), Albuquerque
New YorkPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073), Mineola
Laura and Isaac Perlmutter Cancer Center ( Site 0003), New York
TennesseeSCRI Oncology Partners ( Site 7004), Nashville
Tennessee Oncology ( Site 0018), Nashville
TexasTexas Oncology - DFW ( Site 8007), Dallas
Texas Oncology - West Texas ( Site 8004), El Paso
Kelsey-Seybold Clinic ( Site 0040), Houston
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096), Houston
Texas Oncology - San Antonio ( Site 8001), San Antonio
UtahUniversity of Utah, Huntsman Cancer Institute ( Site 0056), Salt Lake City
VirginiaVirginia Oncology Associates (VOA) ( Site 8002), Norfolk
WashingtonFred Hutchinson Cancer Center ( Site 0042), Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.