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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06841354

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Rescue Medication (drug), Paclitaxel (drug)
How long the study runs
Study runs about 62 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — biological: IV Infusion · Pembrolizumab — biological: IV Infusion · Rescue Medication — drug: Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. · Paclitaxel — drug: IV Infusion · Nab-paclitaxel — drug: IV Infusion · Gemcitabine — drug: IV Infusion · Carboplatin — drug: IV Infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2025-03-16
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for triple negative breast neoplasms
  • • Phase3 - 1,000 participants
  • • Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with triple negative breast neoplasms

Where?

  • • Truro - Royal Cornwall Hospital ( Site 4003)
  • • London - St Bartholomew's Hospital ( Site 4001)
  • • London - University College London Hospital ( Site 4007)
  • • Nottingham - Nottingham University Hospital NHS Trust ( Site 4009)
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Triple Negative Breast Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1combined positiveHBsAg positive

Treatment history

Treatments you must have had:

  • ✓ completed all prior therapy for early-stage breast cancer with curative intent at least 6 months
  • ✓ recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has locally recurrent unresectable or that has spread TNBC that cannot be treated with curative intent
  • ✓Has not received systemic treatment for locally recurrent unresectable or that has spread breast cancer
  • ✓Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or...
  • ✓Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot take part

  • ✗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 treatment that goes through your whole body for treatment of locally recurrent unresectable or that has spread breast cancer
  • ✗Has Grade ≥2 peripheral neuropathy
See the full 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 Is This Study? (8 UK sites)

Royal Cornwall Hospital ( Site 4003)

Truro TR13LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441872258342

St Bartholomew's Hospital ( Site 4001)

London EC1A7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02073777000

University College London Hospital ( Site 4007)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+447977175703

Nottingham University Hospital NHS Trust ( Site 4009)

Nottingham NG51PB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441159691169

Musgrove Park Hospital ( Site 4005)

Taunton TA1 5DA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441823343634

Queen Elizabeth Hospital Birmingham ( Site 4017)

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441213718766

Velindre Cancer Centre Hospital ( Site 4008)

Cardiff CF142TL, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442920615888

St. James s University Hospital ( Site 4004)

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441132068186

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10