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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)

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…

ClinicalTrials.gov IDNCT06312176

PhasePHASE3

Enrollment1200

SponsorMerck Sharp & Dohme LLC

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Neoplasms

About this study

Interventions

Drug: Sacituzumab tirumotecan — IV infusion
Biological: Pembrolizumab — IV infusion
Drug: Paclitaxel — IV infusion
Drug: Nab-paclitaxel — IV infusion
Drug: Capecitabine — oral tablet
Drug: Liposomal doxorubicin — IV infusion

Primary outcomes

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) (Up to ~40 months)
PFS (Sacituzumab tirumotecan + pembrolizumab versus TPC) (Up to ~40 months)

Eligibility information

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

Study locations

Ironwood Cancer & Research Centers ( Site 0066), Chandler, Arizona 85224 United States
Banner MD Anderson Cancer Center-Oncology ( Site 0004), Gilbert, Arizona 85234 United States
Providence Medical Foundation-Oncology ( Site 0020), Fullerton, California 92835 United States
Moores Cancer Center ( Site 0059), La Jolla, California 92093-0698 United States
Cancer and Blood Specialty Clinic ( Site 0001), Los Alamitos, California 90720 United States
University of Colorado Anschutz Medical Campus ( Site 0061), Aurora, Colorado 80045 United States
UCHealth Cherry Creek Medical Center ( Site 0094), Denver, Colorado 80206 United States
University of Colorado Health - Highlands Ranch Hospital ( Site 0095), Highlands Ranch, Colorado 80129 United States
Yale Cancer Center ( Site 0060), New Haven, Connecticut 06510 United States
Stamford Hospital ( Site 0049), Stamford, Connecticut 06902 United States

Showing 10 of 259 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.