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Phase 3Recruiting

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Sponsored by Merck Sharp & Dohme LLC

About this study

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Where this study is enrolling (41)

  • Banner MD Anderson Cancer Center-Oncology ( Site 0004)

    Gilbert, Arizona

    Call 480-256-6444

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  • Ironwood Cancer & Research Centers ( Site 0066)

    Chandler, Arizona

    Call 480-821-2838

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  • Providence Medical Foundation-Oncology ( Site 0020)

    Fullerton, California

    Call 714-446-5900

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  • Cancer and Blood Specialty Clinic ( Site 0001)

    Los Alamitos, California

    Call 562-353-1200

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  • University of Colorado Anschutz Medical Campus ( Site 0061)

    Aurora, Colorado

    Call 303-724-6077

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Show all 41 locations

  • UCHealth Cherry Creek Medical Center ( Site 0094)

    Denver, Colorado

    Call 720-848-1030

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  • Stamford Hospital ( Site 0049)

    Stamford, Connecticut

    Call 203-276-1000

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  • Yale Cancer Center ( Site 0060)

    New Haven, Connecticut

    Call 203-688-4242

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  • AdventHealth Altamonte Springs ( Site 0021)

    Altamonte Springs, Florida

    Call 407-834-5151

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  • Orlando Health Cancer Institute ( Site 0011)

    Orlando, Florida

    Call 321-843-8370

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  • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)

    Thomasville, Georgia

    Call 229-584-5400

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  • Rush University Medical Center ( Site 0079)

    Chicago, Illinois

    I'm interested

  • University of Chicago Medical Center ( Site 0067)

    Chicago, Illinois

    I'm interested

  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)

    Edgewood, Kentucky

    Call 859-301-4245

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  • Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)

    Baton Rouge, Louisiana

    Call 888-501-4763

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  • Greenebaum Comprehensive Cancer Center ( Site 0036)

    Baltimore, Maryland

    Call 410-328-6373

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  • Holy Cross Hospital ( Site 0073)

    Silver Spring, Maryland

    Call 301-754-7000

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  • Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)

    Boston, Massachusetts

    Call 857-215-3246

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  • Henry Ford Health ( Site 0002)

    Detroit, Michigan

    Call 313-916-2576

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  • Saint Luke's Cancer Institute ( Site 0027)

    Kansas City, Missouri

    Call 816-932-2677

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  • Washington University School of Medicine ( Site 0076)

    St Louis, Missouri

    Call 314-454-8313

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  • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)

    New York, New York

    Call 212-731-6000

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  • NYU Langone Hospital - Long Island ( Site 0090)

    Mineola, New York

    Call 212-731-6000

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  • NYU Langone Health - Brooklyn ( Site 0089)

    Brooklyn, New York

    Call 212-731-6000

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  • Stony Brook University-Cancer Center ( Site 0034)

    Stony Brook, New York

    Call 631-444-4392

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  • Hematology Oncology Associates of Rockland ( Site 0054)

    Nyack, New York

    Call 845-362-1750

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  • Levine Cancer Institute ( Site 0014)

    Charlotte, North Carolina

    Call 980-442-2000

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  • Providence St. Vincent Medical Center ( Site 0081)

    Portland, Oregon

    Call 503-215-2619

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  • Providence Portland Medical Center ( Site 0044)

    Portland, Oregon

    Call 503-215-2619

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  • Thomas Jefferson University - Clinical Research Institute ( Site 0056)

    Philadelphia, Pennsylvania

    Call 215-906-5938

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  • Parkland Health and Hospital System ( Site 0069)

    Dallas, Texas

    Call 214-590-8000

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  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)

    Tyler, Texas

    Call 903-595-7093

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  • The Center for Cancer and Blood Disorders ( Site 0041)

    Fort Worth, Texas

    Call 817-759-7000

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  • Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)

    Dallas, Texas

    Call 214-265-2080

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  • UT Southwestern Medical Center ( Site 0050)

    Dallas, Texas

    Call 214-648-3111

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  • Texas Oncology - San Antonio ( Site 8002)

    San Antonio, Texas

    Call 212-241-0493

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  • Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)

    Midlothian, Virginia

    Call 804-594-7300

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  • Inova Schar Cancer Institute ( Site 0025)

    Fairfax, Virginia

    Call 571-472-4724

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  • VCU Health Adult Outpatient Pavillion ( Site 0070)

    Richmond, Virginia

    Call 877-462-7739

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  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)

    Roanoke, Virginia

    Call 844-482-4812

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  • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)

    Madison, Wisconsin

    Call 800-622-8922

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Who can participate

Inclusion criteria

  • ✓Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  • ✓Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
  • ✓Is a chemotherapy candidate
  • ✓Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
  • ✓Has adequate organ function
  • ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
  • ✓Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • ✓Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion criteria

  • ✕Has breast cancer amenable to treatment with curative intent
  • ✕Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
  • ✕Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
  • ✕Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
  • ✕Active autoimmune disease that has required systemic treatment in the past 2 years
  • ✕History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
  • ✕Has an active infection requiring systemic therapy

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.