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)

Recruiting now · Phase 3

Conditions studied: Triple Negative Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06841354

Run by

Merck Sharp & Dohme LLC

People needed

1000

Starts

2025-03-16

Expected to finish

2030-05-18

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ironwood Cancer & Research Centers ( Site 0036) — Chandler, Arizona, United States (enrolling)
• USA Mitchell Cancer Institute ( Site 0090) — Mobile, Alabama, United States (enrolling)
• City of Hope Lennar Foundation Cancer Center ( Site 0099) — Irvine, California, United States (enrolling)
• UCLA Department of Medicine - Hematology & Oncology ( Site 0047) — Los Angeles, California, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016) — San Francisco, California, United States (enrolling)
• City of Hope ( Site 0097) — Duarte, California, United States (enrolling)
• Washington Hospital Center ( Site 0098) — Washington D.C., District of Columbia, United States (enrolling)
• AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007) — Altamonte Springs, Florida, United States (enrolling)
• Orlando Health Cancer Institute ( Site 0012) — Orlando, Florida, United States (enrolling)
• Florida Cancer Specialists - East ( Site 7000) — West Palm Beach, Florida, United States (enrolling)
• University Cancer & Blood Center, LLC ( Site 0023) — Athens, Georgia, United States (enrolling)
• St. Luke's Cancer Institute: Boise ( Site 0037) — Boise, Idaho, United States (enrolling)
• University of Illinois Cancer Center ( Site 0044) — Chicago, Illinois, United States (enrolling)
• MedStar Franklin Square Medical Center ( Site 0031) — Baltimore, Maryland, United States (enrolling)
• MedStar Good Samaritan Hospital ( Site 0079) — Baltimore, Maryland, United States (enrolling)
• MedStar Southern Maryland Hospital Center ( Site 0100) — Clinton, Maryland, United States (enrolling)
• MedStar Montgomery Medical Center ( Site 0078) — Olney, Maryland, United States (enrolling)
• Holy Cross Hospital ( Site 0091) — Silver Spring, Maryland, United States (enrolling)
• Cancer & Hematology Centers of Western Michigan ( Site 0026) — Grand Rapids, Michigan, United States (enrolling)
• Allina Health Cancer Institute ( Site 0069) — Minneapolis, Minnesota, United States (enrolling)
• Hattiesburg Clinic Hematology/Oncology ( Site 0104) — Hattiesburg, Mississippi, United States (enrolling)
• Comprehensive Cancer Centers of Nevada ( Site 0015) — Las Vegas, Nevada, United States (enrolling)
• Renown Regional Medical Center ( Site 0005) — Reno, Nevada, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082) — Hackensack, New Jersey, United States (enrolling)
• New Mexico Oncology Hematology Consultants Ltd. ( Site 0019) — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.