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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06312176

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (drug), Pembrolizumab (biological), Paclitaxel (drug), Nab-paclitaxel (drug)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — drug: IV infusion · Pembrolizumab — biological: IV infusion · Paclitaxel — drug: IV infusion · Nab-paclitaxel — drug: IV infusion · Capecitabine — drug: oral tablet · Liposomal doxorubicin — drug: IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,200
Started
2024-04-14
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Phase3 - 1,200 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • Londonderry - North West Cancer Centre ( Site 1944)
  • • Truro - The Royal Cornwall Hospital ( Site 1943)
  • • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
  • • London - University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Breast Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2receptor positivereceptor 2 negative

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy

What the study is looking for

  • ✓Has unresectable that has grown locally or that has spread centrally-confirmed hormone receptor positive (HR+)/human epidermal...
  • ✓Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally...
  • ✓Is a drug treatment candidate
  • ✓Has an activity scale (ECOG) performance status of 0 to 1 assessed within 7 days before...
  • ✓Has healthy organ

Who cannot take part

  • ✗Has breast cancer amenable to treatment with curative intent
  • ✗Has experienced an early recurrence (\<6 months after completing after surgery/before surgery drug treatment) and therefore is...
  • ✗Has causing symptoms advanced/that has spread visceral spread at risk of rapidly evolving into life-threatening complications
  • ✗Has received prior drug treatment for unresectable that has grown locally or that has spread breast cancer
  • ✗Active autoimmune disease that has required systemic treatment in the past 2 years
See the full 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 Is This Study? (6 UK sites)

North West Cancer Centre ( Site 1944)

Londonderry BT47 6SB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02871320781

The Royal Cornwall Hospital ( Site 1943)

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441872258343

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator1-888-577-8839

University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator1-888-577-8839

Blackpool Victoria Hospital ( Site 1941)

Blackpool FY3 8NR, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01253 951524

City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator441159691169

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10