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Treatment for triple-negative breast cancer using sacituzumab tirumotecan and pembrolizumab

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)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06841354

This study is testing if a new treatment combining sacituzumab tirumotecan and pembrolizumab can help people with triple-negative breast cancer live longer and keep their cancer from getting worse compared to regular chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, sacituzumab, chemotherapy
Locations258 sites (Mobile, Alabama and 257 other locations)
Trial IDNCT06841354 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of sacituzumab tirumotecan, both alone and in combination with pembrolizumab, in treating patients with triple-negative breast cancer (TNBC). The primary objective is to determine whether this treatment regimen can improve overall survival and prevent cancer progression compared to standard chemotherapy. Participants will be monitored for their response to the treatment and any potential side effects. The study aims to provide insights into new therapeutic options for patients with advanced TNBC.

Who should consider this trial

Good fit: Ideal candidates are individuals with locally recurrent unresectable or metastatic triple-negative breast cancer who have not received prior systemic treatment for their condition.

Not a fit: Patients with early-stage breast cancer who have not experienced recurrence or those who have already received systemic treatment for metastatic TNBC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with triple-negative breast cancer, potentially improving survival rates.

How similar studies have performed: Previous studies have shown promising results with similar immunotherapy approaches in treating triple-negative breast cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Mobile, Alabama and 257 other locations

+208 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast NeoplasmsProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2Antibody-drug conjugateTrophoblast cell-surface antigen 2
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.