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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
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Alemán
Recruiting
Instituto de Oncologia Saint Gallen
Recruiting
Hospital Mãe de Deus - Porto Alegre
Hospital Moinhos de Vento
Recruiting
Vencer e Oncoclinica - Oncoclínica Oncologistas Associados
Recruiting
StudyMK 2870-010
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06312176
