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)

NCT06312176 · tracked via the Priya Life Science India tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2024-04-14

Last updated

2026-09-03

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanPembrolizumabPaclitaxelNab-paclitaxelCapecitabineLiposomal doxorubicin

Sacituzumab tirumotecan: IV infusion

Pembrolizumab: IV infusion

Paclitaxel: IV infusion

Nab-paclitaxel: IV infusion

Capecitabine: oral tablet

Liposomal doxorubicin: IV infusion

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) — Up to ~38 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

Trial sites (259)

Facility	City	Region	Status
Ironwood Cancer & Research Centers ( Site 0066)	Chandler	Arizona	Recruiting
Banner MD Anderson Cancer Center-Oncology ( Site 0004)	Gilbert	Arizona	Recruiting
Providence Medical Foundation-Oncology ( Site 0020)	Fullerton	California	Recruiting
Moores Cancer Center ( Site 0059)	La Jolla	California	Active Not Recruiting
Cancer and Blood Specialty Clinic ( Site 0001)	Los Alamitos	California	Recruiting
University of Colorado Anschutz Medical Campus ( Site 0061)	Aurora	Colorado	Recruiting
UCHealth Cherry Creek Medical Center ( Site 0094)	Denver	Colorado	Recruiting
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)	Highlands Ranch	Colorado	Completed
Yale Cancer Center ( Site 0060)	New Haven	Connecticut	Recruiting
Stamford Hospital ( Site 0049)	Stamford	Connecticut	Recruiting
AdventHealth Altamonte Springs ( Site 0021)	Altamonte Springs	Florida	Recruiting
University of Florida College of Medicine ( Site 0063)	Gainesville	Florida	Active Not Recruiting
Orlando Health Cancer Institute ( Site 0011)	Orlando	Florida	Recruiting
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)	Thomasville	Georgia	Recruiting
Rush University Medical Center ( Site 0079)	Chicago	Illinois	Recruiting
University of Chicago Medical Center ( Site 0067)	Chicago	Illinois	Recruiting
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)	Edgewood	Kentucky	Recruiting
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)	Baton Rouge	Louisiana	Recruiting
Greenebaum Comprehensive Cancer Center ( Site 0036)	Baltimore	Maryland	Recruiting
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)	Baltimore	Maryland	Completed
Holy Cross Hospital ( Site 0073)	Silver Spring	Maryland	Recruiting
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)	Boston	Massachusetts	Recruiting
Henry Ford Health ( Site 0002)	Detroit	Michigan	Recruiting
Saint Luke's Cancer Institute ( Site 0027)	Kansas City	Missouri	Recruiting
Washington University School of Medicine ( Site 0076)	St Louis	Missouri	Recruiting
NYU Langone Health - Brooklyn ( Site 0089)	Brooklyn	New York	Recruiting
NYU Langone Hospital - Long Island ( Site 0090)	Mineola	New York	Recruiting
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)	New York	New York	Recruiting
Hematology Oncology Associates of Rockland ( Site 0054)	Nyack	New York	Recruiting
Stony Brook University-Cancer Center ( Site 0034)	Stony Brook	New York	Recruiting
Levine Cancer Institute ( Site 0014)	Charlotte	North Carolina	Recruiting
Zangmeister Cancer Center ( Site 7000)	Columbus	Ohio	Completed
Providence Portland Medical Center ( Site 0044)	Portland	Oregon	Recruiting
Providence St. Vincent Medical Center ( Site 0081)	Portland	Oregon	Recruiting
Thomas Jefferson University - Clinical Research Institute ( Site 0056)	Philadelphia	Pennsylvania	Recruiting
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)	Dallas	Texas	Recruiting
Parkland Health and Hospital System ( Site 0069)	Dallas	Texas	Recruiting
UT Southwestern Medical Center ( Site 0050)	Dallas	Texas	Recruiting
The Center for Cancer and Blood Disorders ( Site 0041)	Fort Worth	Texas	Recruiting
Texas Oncology - San Antonio ( Site 8002)	San Antonio	Texas	Recruiting

+ 219 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06312176 on ClinicalTrials.gov ↗ ← All trials in India