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)
Recruiting · NCT06312176 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 21 US states.
- Ironwood Cancer & Research Centers ( Site 0066) - Chandler, Arizona, United States
- Banner MD Anderson Cancer Center-Oncology ( Site 0004) - Gilbert, Arizona, United States
- Providence Medical Foundation-Oncology ( Site 0020) - Fullerton, California, United States
- Moores Cancer Center ( Site 0059) - La Jolla, California, United States
- Cancer and Blood Specialty Clinic ( Site 0001) - Los Alamitos, California, United States
- University of Colorado Anschutz Medical Campus ( Site 0061) - Aurora, Colorado, United States
- UCHealth Cherry Creek Medical Center ( Site 0094) - Denver, Colorado, United States
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095) - Highlands Ranch, Colorado, United States
- Yale Cancer Center ( Site 0060) - New Haven, Connecticut, United States
- Stamford Hospital ( Site 0049) - Stamford, Connecticut, United States
- AdventHealth Altamonte Springs ( Site 0021) - Altamonte Springs, Florida, United States
- University of Florida College of Medicine ( Site 0063) - Gainesville, Florida, United States
- Orlando Health Cancer Institute ( Site 0011) - Orlando, Florida, United States
- Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) - Thomasville, Georgia, United States
- Rush University Medical Center ( Site 0079) - Chicago, Illinois, United States
- University of Chicago Medical Center ( Site 0067) - Chicago, Illinois, United States
- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053) - Edgewood, Kentucky, United States
- Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042) - Baton Rouge, Louisiana, United States
- Greenebaum Comprehensive Cancer Center ( Site 0036) - Baltimore, Maryland, United States
- Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) - Baltimore, Maryland, United States
- Holy Cross Hospital ( Site 0073) - Silver Spring, Maryland, United States
- Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037) - Boston, Massachusetts, United States
- Henry Ford Health ( Site 0002) - Detroit, Michigan, United States
- Saint Luke's Cancer Institute ( Site 0027) - Kansas City, Missouri, United States
- Washington University School of Medicine ( Site 0076) - St Louis, Missouri, United States
- NYU Langone Health - Brooklyn ( Site 0089) - Brooklyn, New York, United States
- NYU Langone Hospital - Long Island ( Site 0090) - Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068) - New York, New York, United States
- Hematology Oncology Associates of Rockland ( Site 0054) - Nyack, New York, United States
- Stony Brook University-Cancer Center ( Site 0034) - Stony Brook, New York, United States
- Levine Cancer Institute ( Site 0014) - Charlotte, North Carolina, United States
- Zangmeister Cancer Center ( Site 7000) - Columbus, Ohio, United States
- Providence Portland Medical Center ( Site 0044) - Portland, Oregon, United States
- Providence St. Vincent Medical Center ( Site 0081) - Portland, Oregon, United States
- Thomas Jefferson University - Clinical Research Institute ( Site 0056) - Philadelphia, Pennsylvania, United States
- Texas Oncology-Dallas Presbyterian Hospital ( Site 8000) - Dallas, Texas, United States
- Parkland Health and Hospital System ( Site 0069) - Dallas, Texas, United States
- UT Southwestern Medical Center ( Site 0050) - Dallas, Texas, United States
- The Center for Cancer and Blood Disorders ( Site 0041) - Fort Worth, Texas, United States
- Texas Oncology - San Antonio ( Site 8002) - San Antonio, Texas, United States
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057) - Tyler, Texas, United States
- Inova Schar Cancer Institute ( Site 0025) - Fairfax, Virginia, United States
- Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015) - Midlothian, Virginia, United States
- VCU Health Adult Outpatient Pavillion ( Site 0070) - Richmond, Virginia, United States
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001) - Roanoke, Virginia, United States
- University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040) - Madison, Wisconsin, United States
- Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876) - Adana, Turkey (Türkiye)
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870) - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi-Medical Oncology ( Site 1874) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871) - Ankara, Turkey (Türkiye)
- Bradford Hill Norte ( Site 0456) - Antofagasta, Chile
- Auckland City Hospital ( Site 2031) - Auckland, New Zealand
- Hospital Universitari Vall d'Hebron-Oncology ( Site 1750) - Barcelona, Spain
- Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314) - Berlin, Germany
- Blackpool Victoria Hospital ( Site 1941) - Blackpool, United Kingdom
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474) - Bologna, Italy
- Centrul Medical Neolife- Baneasa ( Site 1704) - Bucharest, Romania
- Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381) - Budapest, Hungary
- Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373) - Budapest, Hungary
- Hospital Aleman-Oncology ( Site 0386) - Buenos Aires, Argentina
Showing 60 of 259 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →