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Phase 3Recruiting

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)

Sponsored by Merck Sharp & Dohme LLC

About this study

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.

Where this study is enrolling (37)

  • USA Mitchell Cancer Institute ( Site 0090)

    Mobile, Alabama

    Call 251-410-4924

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  • Ironwood Cancer & Research Centers ( Site 0036)

    Chandler, Arizona

    Call 623-312-3000

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  • City of Hope ( Site 0097)

    Duarte, California

    Call 626-218-9845

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  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)

    San Francisco, California

    Call 415-353-7070

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  • City of Hope Lennar Foundation Cancer Center ( Site 0099)

    Irvine, California

    Call 626-218-0720

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Show all 37 locations

  • UCLA Department of Medicine - Hematology & Oncology ( Site 0047)

    Los Angeles, California

    Call 650-283-5067

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  • Washington Hospital Center ( Site 0098)

    Washington D.C., District of Columbia

    Call 202-877-8839

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  • Orlando Health Cancer Institute ( Site 0012)

    Orlando, Florida

    Call 321-841-8284

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  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida

    Call 561-366-4100

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  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)

    Altamonte Springs, Florida

    Call 407-303-2284

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  • University Cancer & Blood Center, LLC ( Site 0023)

    Athens, Georgia

    Call 706-353-2990

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  • St. Luke's Cancer Institute: Boise ( Site 0037)

    Boise, Idaho

    Call 208-381-2711

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  • University of Illinois Cancer Center ( Site 0044)

    Chicago, Illinois

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  • MedStar Montgomery Medical Center ( Site 0078)

    Olney, Maryland

    Call 301-774-8882

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  • MedStar Southern Maryland Hospital Center ( Site 0100)

    Clinton, Maryland

    Call 301-877-4673

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  • Holy Cross Hospital ( Site 0091)

    Silver Spring, Maryland

    Call 301-754-7552

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  • MedStar Franklin Square Medical Center ( Site 0031)

    Baltimore, Maryland

    Call 443-777-7147

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  • MedStar Good Samaritan Hospital ( Site 0079)

    Baltimore, Maryland

    Call 443-777-7147

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  • Cancer & Hematology Centers of Western Michigan ( Site 0026)

    Grand Rapids, Michigan

    Call 616-954-9800

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  • Allina Health Cancer Institute ( Site 0069)

    Minneapolis, Minnesota

    Call 763-577-7000

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  • Hattiesburg Clinic Hematology/Oncology ( Site 0104)

    Hattiesburg, Mississippi

    Call 601-261-1700

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  • Renown Regional Medical Center ( Site 0005)

    Reno, Nevada

    Call 775-982-5050

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  • Comprehensive Cancer Centers of Nevada ( Site 0015)

    Las Vegas, Nevada

    Call 702-952-3350

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  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)

    Hackensack, New Jersey

    Call 551-996-5900

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

    Albuquerque, New Mexico

    Call 505-842-8171

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  • Laura and Isaac Perlmutter Cancer Center ( Site 0003)

    New York, New York

    Call 212-731-6126

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  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)

    Mineola, New York

    Call 516-663-9500

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  • Tennessee Oncology ( Site 0018)

    Nashville, Tennessee

    Call 877-836-6662

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  • SCRI Oncology Partners ( Site 7004)

    Nashville, Tennessee

    Call 615-329-7274

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  • Texas Oncology - West Texas ( Site 8004)

    El Paso, Texas

    Call 915-747-4835

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  • Kelsey-Seybold Clinic ( Site 0040)

    Houston, Texas

    Call 713-442-0000

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  • Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)

    Houston, Texas

    Call 713-442-1700

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  • Texas Oncology - DFW ( Site 8007)

    Dallas, Texas

    Call 214-739-4175

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  • Texas Oncology - San Antonio ( Site 8001)

    San Antonio, Texas

    Call 210-419-2608

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  • University of Utah, Huntsman Cancer Institute ( Site 0056)

    Salt Lake City, Utah

    Call 801-587-7000

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  • Virginia Oncology Associates (VOA) ( Site 8002)

    Norfolk, Virginia

    Call 757-368-5033

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  • Fred Hutchinson Cancer Center ( Site 0042)

    Seattle, Washington

    Call 206-606-6329

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.