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)

Official record

Identifier

NCT06312176

Recruiting locations

countries

United StatesArgentinaAustraliaBelgiumBrazilCanadaChileColombiaCosta RicaCzechiaDenmarkFranceGermanyGreeceHong KongHungaryIndiaIrelandIsraelItalyJapanMalaysiaMexicoNetherlandsNew ZealandPeruPhilippinesPolandPortugalPuerto RicoRomaniaSingaporeSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom

Interventions studied

Sacituzumab tirumotecanPembrolizumabPaclitaxelNab-paclitaxelCapecitabineLiposomal doxorubicin

Lead sponsor

Merck Sharp & Dohme LLC

Target enrolment

1200 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Mar 15, 2024

Last updated on the registry

Sep 25, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Breast Cancer