protocolSection identificationModule nctId: NCT06274515, orgStudyIdInfo id: WO44977, briefTitle: A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies, acronym: REMERGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-01-28, completionDateStruct date: 2027-01-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hoffmann-La Roche, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Tissue and Blood Draw, outcomesModule primaryOutcomes measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1), primaryOutcomes measure: Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1), primaryOutcomes measure: Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1), primaryOutcomes measure: Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie, status: RECRUITING, city: Essen, zip: 45136, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: I.R.S.T Srl IRCCS; Oncologia Medica, status: RECRUITING, city: Meldola, state: Emilia-Romagna, zip: 47014, country: Italy, geoPoint lat: 44.12775, lon: 12.0626, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Rome, state: Lazio, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False