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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)

NCT06312176 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Sacituzumab tirumotecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Capecitabine

oral tablet

DRUG

Liposomal doxorubicin

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2027-07-11
Completion
2031-04-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312176 on ClinicalTrials.gov