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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)

1200 patients around the world
Available in Puerto Rico, Chile, Costa Rica, Argentina, United States
Merck Sharp & Dohme LLC
33Research sites
1200Patients around the world

This study is for people with

Breast Cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
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.

Sites

Sociedad de Beneficencia Hospital Italiano - Córdoba
Roma 550, Bº General Paz, Córdoba
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Av. Galvan 4102, CABA, Buenos Aires
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Dorrego 269, La Rioja
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Italia 428, Rosario - Santa Fe
Hospital Alemán
Av. Pueyrredón 1640, CABA, Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Av. Crámer 1180, CABA, Buenos Aires
Hospital Mãe de Deus - Porto Alegre
R. José de Alencar, 286 - Menino Deus, Porto Alegre - RS, 90880-481, Brazil
ICB - Instituto do Câncer Brasil - Unidade Taubaté
Recruiting
Av. John Fitzgerald Kenedy, 973 - Jardim das Nações, Taubaté - SP, 12030-200, Brazil
Instituto de Oncologia Saint Gallen
Recruiting
R. Mal. Deodoro, 1139 - Bonfim, Santa Cruz do Sul - RS, 96810-102, Brazil
IBCC - Núcleo de Pesquisa e Ensino
Recruiting
Av. Alcântara Machado, 2576 - Brás, São Paulo - SP, 03102-002, Brazil
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