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RecruitingLast updated: 2 June 2026

TroFuse-011: A study recruiting people with advanced triple negative breast cancer expressing PD-L1 to evaluate how well a targeted treatment called sacituzumab tirumotecan works alone and in combination with immunotherapy compared to immunotherapyA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

TroFuse-011

Clinical summary

Summary

You may be eligible for this study if you have previously untreated locally recurrent, unresectable or metastatic triple negative breast cancer that is expressing PD-L1 at CPS < 10.

Researchers want to know whether sacituzumab tirumotecan, which is an antibody-drug conjugate, given alone or with pembrolizumab immunotherapy can treat triple negative breast cancer. The main goal of the study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compard to people treated with chemotherapy.

Eligible participants will be randomly allocated (by chance) to one of three treatment arms.

  • Arm A: will receive sacituzumab tirumotecan intravenously (IV) every 2 weeks
  • Arm B: will receive sacituzumab tirumotecan IV every 2 weeks plus pembrolizumab IV every 6 weeks
  • Arm C: will receive physician's choice of chemotherapy, which may include paclitaxel, nab-paclitaxel, gemcitabine and carboplatin.

Conditions

This trial is treating people with locally recurrent, unresectable or metastatic triple negative breast cancer that cannot be treated with curative intent, and have not received systemic treatment for their advanced disease

Eligibility

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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06841354 *
  • 2024-516834-36-00 *
  • 2870-011; MK-2870-011; TROFUSE-011; U1111-1311-2310; MK2870-011

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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

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