[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402922":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":10,"locations":37,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Roswell Park Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Basic science (medical chart review, biospecimen collection)",null,"Patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis\u002Ftreatment decision, biomarker assessments, and description of mechanisms of resistance\u002Fresponse related to ciclib-therapy.",[13,14,15],"Other: Cytology Specimen Collection Procedure","Other: Diagnostic Laboratory Biomarker Analysis","Other: Medical Chart Review",[17,23,27],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"Cytology Specimen Collection Procedure","Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples",[9],[22],"Cytologic Sampling",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Diagnostic Laboratory Biomarker Analysis","Correlative studies",[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Medical Chart Review","Patient's electronic health records are reviewed",[9],[32],"Chart Review",[34],{"name":35,"affiliation":5,"role":36},"Agnieszka K Witkiewicz","PRINCIPAL_INVESTIGATOR",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Buffalo","New York","14263","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-78.87837,42.88645,{"lat":49,"lon":48},[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Agnieszka K. Witkiewicz","CONTACT","716-845-1224","Agnieszka.Witkiewicz@roswellpark.org",{"name":53,"role":36,"phone":10,"phoneExt":10,"email":10},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100402922","biomarkers-and-clinical-features-of-metastatic-breast-cancer-in-patients-treated-with-cdk46-inhibitors-100402922",false,"NCT04526587","Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4\u002F6 Inhibitors","The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced\u002FMetastatic Breast Cancer Treated With CDK4\u002F6 Inhibitors","Inclusion Criteria:\n\n* All adult patients with ER+\u002FHER2- metastatic breast cancer or HR+\u002FHER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study\n\n  * This includes patients receiving standard of care therapy for ER+\u002FHER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital\n  * Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy\n* Participant must understand the prospective nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form\n\nExclusion Criteria:\n\n* Pregnant of nursing female subjects\n* Unwilling or unable to follow protocol requirements","ALL","18 Years",{"count":70,"type":71},700,"ESTIMATED","OBSERVATIONAL","This study investigates the clinical course of CDK4\u002F6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4\u002F6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.",[75,76,77],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Prognostic Stage IV Breast Cancer AJCC v8","2025-11-11",{"date":80,"type":81},"2025-11-13","ACTUAL",{"date":83,"type":81},"2020-07-03",{"date":85,"type":71},"2035-07-03",{"name":5,"class":6},1]