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Comparing sacituzumab tirumotecan and pembrolizumab to standard treatment for advanced breast cancer

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06312176

This study is testing if a new treatment combining sacituzumab tirumotecan and pembrolizumab can help people with advanced breast cancer live longer without their disease getting worse compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1200 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionschemotherapy, sacituzumab, pembrolizumab
Locations258 sites (Chandler, Arizona and 257 other locations)
Trial IDNCT06312176 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sacituzumab tirumotecan, both as a standalone treatment and in combination with pembrolizumab, against the treatment of physician's choice for patients with hormone receptor positive and HER2 negative unresectable locally advanced or metastatic breast cancer. The primary goal is to determine if these treatments can improve progression-free survival compared to standard options. Participants will be monitored for disease progression using established criteria, ensuring a rigorous assessment of treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are individuals with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have experienced disease progression on prior endocrine therapies.

Not a fit: Patients with resectable breast cancer or those who have not progressed on prior endocrine therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar immunotherapy approaches in breast cancer, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chandler, Arizona and 257 other locations

+208 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.