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951524",{"facility":3079,"status":78,"city":3080,"state":73,"zip":3081,"country":3024,"cosmosGeoPoint":3082,"geoPoint":3086,"contacts":3087},"City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)","Nottingham","NG5 1PB",{"type":84,"coordinates":3083},[3084,3085],-1.15047,52.9536,{"lat":3085,"lon":3084},[3088],{"name":91,"role":71,"phone":3089,"phoneExt":73,"email":73},"441159691169",{"type":3091,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR","100540079",false,"NCT06312176","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+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)","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+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer\n* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, with one in combination with a CDK4\u002F6 inhibitor\n* Is a chemotherapy candidate\n* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n* Has adequate organ function\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* 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\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has breast cancer amenable to treatment with curative intent\n* Has experienced an early recurrence (\\\u003C6 months after completing adjuvant\u002Fneoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment\n* Has symptomatic advanced\u002Fmetastatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that requires steroids, or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy","ALL","18 Years",{"count":3101,"type":3102},1200,"ESTIMATED","INTERVENTIONAL",[3105],"PHASE3","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\u002Fhuman epidermal growth factor receptor-2 negative (HR+\u002FHER2-) unresectable locally advanced, or metastatic, breast cancer.\n\nThe 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.",[3108],"Breast Neoplasms",[3110,3111,3112],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","2026-06-26",{"date":3115,"type":3116},"2026-06-29","ACTUAL",{"date":3118,"type":3116},"2024-04-14",{"date":3120,"type":3102},"2031-04-12",{"name":5,"class":6},259]