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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)

RecruitingPhase 3

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the 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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,200 · Started: Apr 14, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06312176

Locations in the U.S.

ArizonaIronwood Cancer & Research Centers ( Site 0066), Chandler
Banner MD Anderson Cancer Center-Oncology ( Site 0004), Gilbert
CaliforniaProvidence Medical Foundation-Oncology ( Site 0020), Fullerton
ColoradoUniversity of Colorado Anschutz Medical Campus ( Site 0061), Aurora
UCHealth Cherry Creek Medical Center ( Site 0094), Denver
ConnecticutYale Cancer Center ( Site 0060), New Haven
Stamford Hospital ( Site 0049), Stamford
FloridaAdventHealth Altamonte Springs ( Site 0021), Altamonte Springs
Orlando Health Cancer Institute ( Site 0011), Orlando
GeorgiaArchbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032), Thomasville
IllinoisRush University Medical Center ( Site 0079), Chicago
KentuckySaint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053), Edgewood
LouisianaMary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042), Baton Rouge
MarylandGreenebaum Comprehensive Cancer Center ( Site 0036), Baltimore
Holy Cross Hospital ( Site 0073), Silver Spring
MassachusettsDana-Farber Cancer Institute-Breast Oncology Center ( Site 0037), Boston
MichiganHenry Ford Health ( Site 0002), Detroit
MissouriSaint Luke's Cancer Institute ( Site 0027), Kansas City
Washington University School of Medicine ( Site 0076), St Louis
New YorkNYU Langone Health - Brooklyn ( Site 0089), Brooklyn
NYU Langone Hospital - Long Island ( Site 0090), Mineola
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068), New York
Hematology Oncology Associates of Rockland ( Site 0054), Nyack
Stony Brook University-Cancer Center ( Site 0034), Stony Brook
North CarolinaLevine Cancer Institute ( Site 0014), Charlotte
OregonProvidence Portland Medical Center ( Site 0044), Portland
Providence St. Vincent Medical Center ( Site 0081), Portland
PennsylvaniaThomas Jefferson University - Clinical Research Institute ( Site 0056), Philadelphia
TexasParkland Health and Hospital System ( Site 0069), Dallas
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000), Dallas
UT Southwestern Medical Center ( Site 0050), Dallas
The Center for Cancer and Blood Disorders ( Site 0041), Fort Worth
Texas Oncology - San Antonio ( Site 8002), San Antonio
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057), Tyler
VirginiaInova Schar Cancer Institute ( Site 0025), Fairfax
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015), Midlothian
VCU Health Adult Outpatient Pavillion ( Site 0070), Richmond
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001), Roanoke
WisconsinUniversity Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040), Madison

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.