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Study of Sacituzumab Tirumotecan for Triple-Negative Breast Cancer

This study is looking into new ways to treat triple-negative breast cancer (TNBC). Researchers want to see if sacituzumab tirumotecan, given alone or with pembrolizumab, can help people live longer or prevent their cancer from growing or spreading, compared to standard chemotherapy like paclitaxel or nab-paclitaxel. You might be able to join if you have TNBC that has come back locally and can't be removed, or if it has spread to other parts of your body, and you haven't had treatment for this advanced cancer yet. The study aims to enroll about 1000 participants. Before receiving sacituzumab tirumotecan, you will get pre-medications to help manage potential side effects.

Study design
This interventional study is comparing sacituzumab tirumotecan, alone or with pembrolizumab, against standard chemotherapy. It plans to enroll about 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be followed for up to approximately 39 months to measure how long you live without the cancer growing, and for up to approximately 61 months to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06841354

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
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,000 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumabRescue MedicationPaclitaxelNab-paclitaxelGemcitabine

At a glance

Recruiting sites
265 of 271 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
Measured over Up to ~39 months
+1 more outcome measured

Conditions

Triple Negative Breast Neoplasms

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Where it's being run

271 sites across 166 states
Japan8
Italy7
Turkey (Türkiye)7
Quebec6
Tokyo6
Maryland5
Texas5
Israel5

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)Up to ~39 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

  • Overall Survival (OS) (sac-TMT versus TPC)Up to ~61 months

    OS is defined as the time from randomization to death due to any cause.