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Study of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

This study is testing sacituzumab tirumotecan, alone or with pembrolizumab, for people with hormone receptor positive (HR+)/HER2-negative (HER2-) breast cancer that has spread or cannot be removed. You might be able to join if your cancer has progressed after certain hormone therapies, including one with a CDK4/6 inhibitor. Researchers want to see if these treatments can keep the cancer from growing for longer compared to standard treatments chosen by your doctor. The study is looking for about 1200 participants.

Study design
This is an interventional study comparing sacituzumab tirumotecan (alone or with pembrolizumab) to standard treatments, involving approximately 1200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants live without their cancer growing (progression-free survival) for up to about 38 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06312176

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
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,200 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumabPaclitaxelNab-paclitaxelCapecitabineLiposomal doxorubicin

At a glance

Recruiting sites
230 of 259 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
Measured over Up to ~38 months

Conditions

Breast Neoplasms

Explore related trials

Breast Carcinoma

Where it's being run

259 sites across 151 states
Japan8
Texas6
Taiwan6
Turkey (Türkiye)6
New York5
Region M. de Santiago5
Tokyo5
Virginia4

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.