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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

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

NCT06312176•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

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

Locations (257)

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

Key Dates

Start Date

April 14, 2024

Primary Completion Date

July 11, 2027

Completion Date

April 12, 2031

Last Updated

March 13, 2026

Enrollment

1,200

ESTIMATED participants

Conditions

Breast Neoplasms

Interventions

Sacituzumab tirumotecan

DRUG

Pembrolizumab

BIOLOGICAL

Paclitaxel

DRUG

Nab-paclitaxel

DRUG

Capecitabine

DRUG

Liposomal doxorubicin

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE2

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B

Target-specific immunoPET Imaging of Breast Cancer