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)

Last updated: June 11, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Sacituzumab tirumotecan

Paclitaxel

Gemcitabine

Clinical Study ID

NCT06841354
2870-011
TroFuse-011
MK-2870-011
2024-516834-36
2024-516834-36-00
U1111-1311-2310
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 withcurative intent

  • Has not received systemic treatment for locally recurrent unresectable or metastaticTNBC

  • Participants previously treated for early-stage breast cancer must have completedall prior therapy for early-stage breast cancer with curative intent at least 6months before the first disease recurrence

  • Is a candidate for treatment with one of the TPC options: paclitaxel ornab-paclitaxel or gemcitabine + carboplatin

  • Participants who have AEs due to previous anticancer therapies must have recoveredto ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participantswith endocrine-related AEs who are adequately treated with hormone replacement areeligible

  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey 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 HCVviral load is undetectable

Exclusion

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 atcombined positive score (CPS) ≥10

  • Has received prior systemic therapy for treatment of locally recurrent unresectableor metastatic TNBC

  • Has Grade ≥2 peripheral neuropathy

  • Has history of documented severe dry eye syndrome, severe Meibomian gland diseaseand/or blepharitis, or corneal disease that prevents/delays corneal healing

  • Has active inflammatory bowel disease requiring immunosuppressive medication orprevious 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 evolvinginto life-threatening complications

  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi'ssarcoma and/or Multicentric Castleman's Disease

  • Has known additional malignancy that is progressing or has required active treatmentwithin the past 5 years

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Participants with previously treated brain metastases may participateprovided 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) isallowed

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease

  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBVdeoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCVantibody (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 surgicalcomplications

Study Design

Total Participants: 1000
Treatment Group(s): 7
Primary Treatment: Sacituzumab tirumotecan
Phase: 3
Study Start date:
March 16, 2025
Estimated Completion Date:
May 18, 2030

Connect with a study center

  • Fundacion Estudios Clinicos ( Site 2405)

    Rosario, Santa Fe S2000DEJ
    Argentina

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, Rinat 49100
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, Tal 5265601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 3700)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 3704)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Rabin Medical Center ( Site 3702)

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 3701)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 3703)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Mie University Hospital ( Site 5109)

    Tsu, Mie 514-8507
    Japan

    Active - Recruiting

  • Showa Medical University Hospital ( Site 5103)

    Shinagawa, Tokyo 142-8666
    Japan

    Active - Recruiting

  • Seoul National University Bundang Hospital ( Site 5204)

    Seongnam, Kyonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital ( Site 5205)

    Daegu, Kyongsangbuk-do 41404
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 5203)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 5200)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System ( Site 5201)

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, Wei-Pang 70403
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 5303)

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 5304)

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 5301)

    Taipei, 104
    Taiwan

    Active - Recruiting

  • Ironwood Cancer & Research Centers ( Site 0036)

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Yale New Haven Hospital ( Site 0001)

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 0015)

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Renown Regional Medical Center ( Site 0005)

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Renown Regional Medical Center (Site number 0005)

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

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