[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548192":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":38,"locations":44,"responsibleParty":97,"collaborators":10,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":10,"studyType":113,"phases":10,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort 1 (N=30)",null,"Locally-advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, either treatment naive or previously exposed to adjuvant therapies, no prior palliative therapy, candidates to receive first-line hormone therapy, primary tumor tissue available.",{"label":13,"type":10,"description":14,"interventionNames":10},"Cohot 2 (N=40)","Locally-advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, progression during hormone therapy plus CDK inhibitor; primary tumor tissue available.",{"label":16,"type":10,"description":17,"interventionNames":10},"Cohort 3 (N=100)","Locally advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, with no disease progression during 6 months of hormonal therapy plus a CDK4\u002F6 inhibitor; with archived tumour tissue available. Patients will be enrolled from the start of therapy with AI plus CDK4\u002F6i in the metastatic setting (index date) up to 6 months into this first-line therapy, provided they have no clinical or radiological evidence of progressive disease. Patients will be followed up until disease progression.",[19,23,26,29,32,35],{"name":20,"affiliation":21,"role":22},"Rodrigo Dienstmann","Oncoclínicas","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":25,"role":22},"Vladmir C. de Lima","FUNDAÇÃO ANTONIO PRUDENTE - A.C. CAMARGO CANCER CENTER",{"name":27,"affiliation":28,"role":22},"Tomas Reinert","IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE",{"name":30,"affiliation":31,"role":22},"Renata Bonadio","INSTITUTO D'OR DE PESQUISA E ENSINO - SÃO PAULO",{"name":33,"affiliation":34,"role":22},"Mayana Lopes","ENSINO E TERAPIA DE INOVAÇÃO CLÍNICA AMO - ÉTICA",{"name":36,"affiliation":37,"role":22},"Leandro Jonata C. de Oliveira","SOCIEDADE BENEFICENTE ISRAELITA BRASILEIRA HOSPITAL ALBERT EISNTEIN",[39],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[45,59,69,78,84,91],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":10},"Ensino E Terapia de Inovação Clínica Amo - Ética","NOT_YET_RECRUITING","Salvador","Estado de Bahia","41.950-640","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-38.49096,-12.97563,{"lat":57,"lon":56},{"facility":60,"status":47,"city":61,"state":62,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Irmandade Da Santa Casa de Misericórdia de Porto Alegre","Porto Alegre","Rio Grande do Sul","90020-090",{"type":54,"coordinates":65},[66,67],-51.23019,-30.03283,{"lat":67,"lon":66},{"facility":70,"status":47,"city":71,"state":10,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":10},"Fundação Antonio Prudente - A.C. Camargo Cancer Center","São Paulo","01.509-900",{"type":54,"coordinates":74},[75,76],-46.63611,-23.5475,{"lat":76,"lon":75},{"facility":79,"status":47,"city":71,"state":10,"zip":80,"country":51,"countryCode":52,"cosmosGeoPoint":81,"geoPoint":83,"contacts":10},"Instituto D'Or de Pesquisa E Ensino - São Paulo","01401-002",{"type":54,"coordinates":82},[75,76],{"lat":76,"lon":75},{"facility":85,"status":86,"city":71,"state":10,"zip":87,"country":51,"countryCode":52,"cosmosGeoPoint":88,"geoPoint":90,"contacts":10},"Research Site","RECRUITING","04513-020",{"type":54,"coordinates":89},[75,76],{"lat":76,"lon":75},{"facility":92,"status":47,"city":71,"state":10,"zip":93,"country":51,"countryCode":52,"cosmosGeoPoint":94,"geoPoint":96,"contacts":10},"Sociedade Beneficente Israelita Brasileira Hospital Albert Eisntein","05652-000",{"type":54,"coordinates":95},[75,76],{"lat":76,"lon":75},{"type":98,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100548192","minimally-interventional-study-on-prevalence-of-emerging-esr1-mutations-in-liquid-biopsy-in-three-cohorts-of-patients-with-breast-cancer-in-comparison-with-patients-baseline-esr1-mutation-status-as-defined-by-tissue-profiling-100548192",false,"NCT06417801","Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.","Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer, With and Without Prior Therapies inMetastatic Setting, and During First-line Aromatase InhibitorPlus CDK4\u002F6 Inhibitor Therapy, in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.","Pangeia-2","Inclusion Criteria:\n\nCohort 1:\n\n* BC patients, male and female,\n* 18 years old and older,\n* Pre or post menopausal,\n* With HR+ (ER and\u002For PR positive) and Her-2 negative (confirmed centrally),\n* Locally advanced irresectable and\u002For metastatic disease\n* Confirmation of HR and Her-2 status may be performed in the primary tumor or in the metastatic lesion (patients with discordant results may be included),\n* Patients must be candidates to CDK4\u002F6i therapy in combination with endocrine therapy in the first line setting (with or without ovarian suppression)\n* Patients may have received one previous line of chemotherapy in the metastatic setting, but no endocrine therapy in the metastatic setting is allowed,\n* Patients may have received chemotherapy in the neo\u002Fadjuvant setting,\n* Patients may have received endocrine therapy (with or without ovarian suppression) in the neo\u002Fadjuvant setting,\n* Patients may have received a CDK4\u002F6i in the adjuvant setting, provided they are still candidates for CDK4\u002F6i therapy in the metastatic setting,\n* Patients must be able to undergo a liquid biopsy procedure before starting their first line treatment,\n* All patients must fill and sign an informed consent form.\n\nCohort 2:\n\n* BC patients,\n* Male and female,\n* 18 years old and older,\n* pre or post menopausal,\n* With HR+ (ER and\u002For PR positive) and Her-2 negative (confirmed centrally),\n* Locally advanced irresectable and\u002For metastatic disease who have progressed on a CDK4\u002F6i in combination with endocrine therapy (with or without ovarian suppression) in the first or second line setting,\n* All other non-conflicting inclusion criteria for cohort 1 apply.\n\nCohort 3:\n\n* BC Patients,\n* Male and female,\n* 18 years or older,\n* pre- or post-menopausal,\n* With HR+ (ER and\u002For PR positive), HER2-negative (centrally confirmed) locally advanced unresectable and\u002For metastatic disease,\n* Confirmation of HR and HER2 status may be performed on the primary tumour or the metastatic lesion (patients with discordant results may be included),\n* Patients must be on first-line hormonal therapy with an aromatase inhibitor plus a CDK4\u002F6 inhibitor (with or without ovarian suppression) for at least 6 months,\n* No clinical or radiological evidence of progressive disease,\n* Patients may have received a prior line of chemotherapy in the metastatic setting; however, prior endocrine therapy in the metastatic setting is not permitted,\n* Patients may have received chemotherapy in the neoadjuvant\u002Fadjuvant setting,\n* Patients may have received endocrine therapy (with or without ovarian suppression) in the neoadjuvant\u002Fadjuvant setting,\n* Patients may have received a CDK4\u002F6 inhibitor in the adjuvant setting, provided they are still eligible for CDK4\u002F6 inhibitor therapy in the metastatic setting,\n* Patients must be able to undergo a liquid biopsy procedure before starting their first-line treatment,\n* All patients must read and sign an Informed Consent Form.\n\nExclusion Criteria:\n\n* Patients WITHOUT HR+ (ER- and\u002For PR-positive)\u002FHER2-negative disease,\n* Patients without radiological and\u002For pathological confirmation of locally unresectable and\u002For metastatic breast cancer,\n* Patients who are NOT candidates for further systemic treatment following a diagnosis of metastatic disease or disease progression,\n* Patients who have already started a CDK4\u002F6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) for first-line metastatic disease (for Cohort 1);\n* Patients who have already started a new line of treatment for metastatic disease following progression on a CDK4\u002F6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) (for Cohort 2);\n* Patients with any suspicion of clinical or radiological disease progression at the time of the first liquid biopsy collection (for Cohort 3),\n* Patients who are NOT able to undergo a liquid biopsy procedure,\n* Patients who are NOT able to provide informed consent.","ALL","18 Years","100 Years",{"count":111,"type":112},170,"ESTIMATED","OBSERVATIONAL","Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4\u002F6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.",[116],"Metastatic Breast Cancer",[118],"Breast Cancer; ER-positive; ESR-1 mutation","2026-06-26",{"date":121,"type":122},"2026-06-30","ACTUAL",{"date":124,"type":122},"2024-06-17",{"date":126,"type":112},"2027-12-30",{"name":5,"class":6},6]