An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer - MK-2870-010

Merck Sharp & Dohme LLC0 个研究点目标入组 1,249 人开始时间: 2024年1月30日最近更新: 2024年7月22日

适应症

试验速览

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•1.Has unresectable locally advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer, 2.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., 3.Is a chemotherapy candidate, 4.Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization, 5.Has adequate organ function, 6.Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy, 7.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, 8.Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

•1.Has breast cancer amenable to treatment with curative intent, 2.Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment, 3.Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications, 4.Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer, 5.Active autoimmune disease that has required systemic treatment in the past 2 years, 6.History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease, 7.Has an active infection requiring systemic therapy

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