[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619124":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":60,"centralContacts":68,"locations":77,"responsibleParty":114,"collaborators":116,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":43,"enrollmentInfo":134,"targetDuration":43,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":100,"whyStopped":43,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8,14,18,22,26,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 Arm A","EXPERIMENTAL","ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant positive or negative and Phosphatidylinositol 3-kinase catalytic subunit alpha \u002F AKT serine\u002Fthreonine kinase \u002F PTEN loss or deletion negative.",[13],"Drug: SERD* + abemaciclib",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 1- Arm B",[17],"Drug: SERD* + everolimus",{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 2 Arm A","ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant negative or positive, and Phosphatidylinositol 3-kinase catalytic subunit alpha \u002F AKT serine\u002Fthreonine kinase \u002F PTEN loss or deletion positive.",[13],{"label":23,"type":10,"description":20,"interventionNames":24},"Cohort 2 Arm B",[25],"Drug: SERD* + everolimus or capecitabine",{"label":27,"type":28,"description":29,"interventionNames":30},"Cohort 3","ACTIVE_COMPARATOR","Triple-Negative Breast Cancer (TNBC): ER- (Estrogen receptor negative), PR- (Progesterone receptor negative), HER2- HER2 negative. AR - = Androgen Receptor negative, PD-L1 (Programmed Death-Ligand 1) positive or negative.",[31],"Drug: SOC",{"label":33,"type":10,"description":34,"interventionNames":35},"Cohort 4","Triple-Negative Breast Cancer (TNBC): ER- (Estrogen receptor negative), PR- (Progesterone receptor negative), HER2- HER2 negative. AR + = Androgen Receptor positive, PD-L1 (Programmed Death-Ligand 1) positive or negative.",[36],"Drug: Antiandrogen",[38,44,48,52,56],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","SERD* + abemaciclib","Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.",[9,19],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"SERD* + everolimus","Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.",[15],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"SERD* + everolimus or capecitabine","Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.",[23],{"type":39,"name":53,"description":54,"armGroupLabels":55,"otherNames":43},"SOC","standard-of-care (SOC) chemotherapy in breast cancer",[27],{"type":39,"name":57,"description":58,"armGroupLabels":59,"otherNames":43},"Antiandrogen","Antiandrogen therapy",[33],[61,64],{"name":62,"affiliation":5,"role":63},"Lisa A Carey, MD","PRINCIPAL_INVESTIGATOR",{"name":65,"affiliation":66,"role":67},"Eric Winer, MD","Yale University","STUDY_CHAIR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":43,"email":73},"Emily L Schworer","CONTACT","919-984-0000","emily_lane@med.unc.edu",{"name":75,"role":71,"phone":43,"phoneExt":43,"email":76},"Ana Gallegos","ana_gallegos@med.unc.edu",[78,98],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Mayo Clinic","NOT_YET_RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-92.4699,44.02163,{"lat":90,"lon":89},[93,96],{"name":94,"role":71,"phone":43,"phoneExt":43,"email":95},"Jen Hager","hager.jennifer@mayo.edu",{"name":97,"role":63,"phone":43,"phoneExt":43,"email":43},"Karthik Giridhar, MD",{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":84,"countryCode":85,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599-7305",{"type":87,"coordinates":105},[106,107],-79.05584,35.9132,{"lat":107,"lon":106},[110,113],{"name":111,"role":71,"phone":112,"phoneExt":43,"email":43},"Lisa A. Carey, MD","919-966-4431",{"name":62,"role":63,"phone":43,"phoneExt":43,"email":43},{"type":115,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[117,120,122],{"name":118,"class":119},"Advanced Research Projects Agency for Health (ARPA-H)","UNKNOWN",{"name":121,"class":6},"Breast Cancer Research Foundation",{"name":123,"class":6},"Translational Breast Cancer Research Consortium","100619124","phase-2-evolutionary-clinical-trial-for-novel-biomarker-driven-therapies-100619124",false,"NCT07340541","Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","EVOLVE-BDT","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years of age at the time of consent\n* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).\n* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol\n\nExclusion Criteria:\n\n* Inaccessible metastatic lesion to research biopsy\n* Subject has already initiated 2nd line therapy\n* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation","ALL","18 Years",{"count":135,"type":136},700,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive\u002Fhormone receptor-negative (ER+\u002FHR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.",[142,143,144,145,146],"Breast Cancer","Metastatic Breast Cancer","Triple Negative Breast Cancer","Estrogen-receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[148,149],"biomarker directed therapies","biomarker stratified trial","2026-05-19",{"date":152,"type":153},"2026-05-20","ACTUAL",{"date":155,"type":153},"2026-02-16",{"date":157,"type":136},"2031-06-02",{"name":5,"class":6},2]