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 now · Phase 3

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06312176

Run by

Merck Sharp & Dohme LLC

People needed

1200

Starts

2024-04-14

Expected to finish

2031-04-12

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• NYU Langone Hospital - Long Island ( Site 0090) — Mineola, New York, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068) — New York, New York, United States (enrolling)
• Ironwood Cancer & Research Centers ( Site 0066) — Chandler, Arizona, United States (enrolling)
• NYU Langone Health - Brooklyn ( Site 0089) — Brooklyn, New York, United States (enrolling)
• Providence Medical Foundation-Oncology ( Site 0020) — Fullerton, California, United States (enrolling)
• UCHealth Cherry Creek Medical Center ( Site 0094) — Denver, Colorado, United States (enrolling)
• Banner MD Anderson Cancer Center-Oncology ( Site 0004) — Gilbert, Arizona, United States (enrolling)
• Yale Cancer Center ( Site 0060) — New Haven, Connecticut, United States (enrolling)
• Cancer and Blood Specialty Clinic ( Site 0001) — Los Alamitos, California, United States (enrolling)
• AdventHealth Altamonte Springs ( Site 0021) — Altamonte Springs, Florida, United States (enrolling)
• University of Colorado Anschutz Medical Campus ( Site 0061) — Aurora, Colorado, United States (enrolling)
• Orlando Health Cancer Institute ( Site 0011) — Orlando, Florida, United States (enrolling)
• Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) — Thomasville, Georgia, United States (enrolling)
• Rush University Medical Center ( Site 0079) — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center ( Site 0067) — Chicago, Illinois, United States (enrolling)
• Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053) — Edgewood, Kentucky, United States (enrolling)
• Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042) — Baton Rouge, Louisiana, United States (enrolling)
• Greenebaum Comprehensive Cancer Center ( Site 0036) — Baltimore, Maryland, United States (enrolling)
• Stamford Hospital ( Site 0049) — Stamford, Connecticut, United States (enrolling)
• Holy Cross Hospital ( Site 0073) — Silver Spring, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037) — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health ( Site 0002) — Detroit, Michigan, United States (enrolling)
• Saint Luke's Cancer Institute ( Site 0027) — Kansas City, Missouri, United States (enrolling)
• Washington University School of Medicine ( Site 0076) — St Louis, Missouri, United States (enrolling)
• Hematology Oncology Associates of Rockland ( Site 0054) — Nyack, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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