protocolSection identificationModule nctId: NCT06312176, orgStudyIdInfo id: 2870-010, secondaryIdInfos id: MK-2870-010, type: OTHER, domain: Merck, secondaryIdInfos id: 2023-504918-29, type: REGISTRY, domain: EU CT, secondaryIdInfos id: U1111-1289-8119, type: OTHER, domain: UTN, briefTitle: A Study of 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), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-13, primaryCompletionDateStruct date: 2027-07-11, completionDateStruct date: 2031-04-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare MK-2870 as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.The primary hypotheses are that MK-2870 as a single agent and MK-2870 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., conditionsModule conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: MK-2870, interventions name: Pembrolizumab, interventions name: Paclitaxel, interventions name: Nab-paclitaxel, interventions name: Capecitabine, interventions name: Liposomal doxorubicin, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) (MK-2870 versus treatment of physician's choice [TPC]; MK-2870 + pembrolizumab versus TPC), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), secondaryOutcomes measure: Change from baseline in physical functioning score, on the EORTC QLQ-C30, secondaryOutcomes measure: Change from baseline in emotional functioning score, on the EORTC QLQ-C30, secondaryOutcomes measure: Change from baseline in fatigue score, on the EORTC QLQ-C30, secondaryOutcomes measure: Change from baseline in diarrhea score, on the EORTC QLQ-C30, secondaryOutcomes measure: Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in physical functioning score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in emotional functioning score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in fatigue score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in diarrhea score, on the EORTC QLQ-C30, secondaryOutcomes measure: Number of participants who experience one or more adverse events (AEs), secondaryOutcomes measure: Number of participants who discontinue study treatment due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rambam Health Care Campus-Oncology Division ( Site 1452), status: RECRUITING, city: Haifa, zip: 3109601, country: Israel, contacts name: Study Coordinator, role: CONTACT, phone: 972-4-777-6700, geoPoint lat: 32.81841, lon: 34.9885, hasResults: False