[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580173":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":16,"overallOfficials":41,"centralContacts":46,"locations":54,"responsibleParty":71,"collaborators":16,"id":73,"slug":16,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":16,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":16,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":57,"whyStopped":16,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Menarini Silicon Biosystems, INC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"The percentage of subjects for which the providers indicated positive impact of the cfDNA\u002FRNA, CTC enumeration, and CTC expression results.","The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA\u002FRNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA\u002FRNA results in subjects with MBC.","3-4 months",[14,18,20,23,25,27],{"measure":15,"description":16,"timeFrame":17},"The correlation of CTC expression and tissue immunohistochemistry (IHC)\u002FIn Situ Hybridization (ISH) results for HER2, ER, and PD-L1.",null,"1 month",{"measure":19,"description":16,"timeFrame":12},"The correlation of CTC expression and cfDNA\u002FRNA results for HER2, ER, and PD-L1.",{"measure":21,"description":16,"timeFrame":22},"The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).","24 months",{"measure":24,"description":16,"timeFrame":22},"The correlation of cfDNA\u002FRNA genomic alterations with response to therapy and PFS.",{"measure":26,"description":16,"timeFrame":22},"The correlation of early cfDNA\u002FRNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +\u002FHER2- MBC.",{"measure":28,"description":16,"timeFrame":22},"The correlation of CTC enumeration results with PFS.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":30,"timePerspective":31,"maskingInfo":16},"COHORT","PROSPECTIVE","A prospective, multicenter, observational study of CellSearch CTC enumeration, CTC HER2, ER, and PD-L1 expression, and MSearch cfDNA\u002FRNA results in subjects with histologically proven MBC. Treatment for MBC will be chosen and performed by treating physicians\u002Fproviders. Eligible subjects will be enrolled after signing the ICF. Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA\u002FRNA assessments at baseline and first restaging as part of Standard of Care (SoC). Subjects will receive any additional cfDNA\u002FRNA assessments as part of research collection. For all subjects 4 to 6 tubes will be collected at baseline and minimally before the first restaging visit. For any subsequent restaging visits a total of 3 to 4 tubes will be collected.","Advanced\u002Fmetastatic breast cancer of following subtypes\u002Flines of systemic therapy in metastatic setting:\n\n* Estrogen Receptor (ER)+\u002FHuman Epidermal growth factor Receptor 2 (HER2) - or Triple Negative (TN) patients prior to starting any line of systemic therapy\n* HER2+ patients prior to starting 2nd line or later therapy",[35,38],{"label":36,"type":16,"description":37,"interventionNames":16},"HR+\u002FHER2- subjects before starting 1st line therapy","Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA\u002FRNA assessments at baseline and first restaging as part of standard of care. Subjects will have additional cfDNA\u002FRNA tests at week 4, and 8.",{"label":39,"type":16,"description":40,"interventionNames":16},"Triple negative starting any line of therapy, HR+\u002FHER2-, and HER2+ starting ≥2nd line therapy","Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA\u002FRNA assessments at baseline and first restaging as part of standard of care.",[42],{"name":43,"affiliation":44,"role":45},"Marija Balic, MD, PhD, MBA","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":16,"email":50},"CONTACT","800-533-8762","balicm@upmc.edu",{"name":52,"role":48,"phone":16,"phoneExt":16,"email":53},"Lisette Stork-Sloots","lstork@medex15.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"UPMC Magee Womens Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-79.99589,40.44062,{"lat":67,"lon":66},[70],{"name":43,"role":48,"phone":16,"phoneExt":16,"email":16},{"type":72,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100580173",false,"NCT06833853","A Study for CTC Expression and cfDNA\u002FRNA Assessment in Metastatic Breast Cancer Patients","CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA\u002FRNA Assessment in Metastatic Breast Cancer","CTC-EXPRESS","Inclusion Criteria:\n\n* Invasive breast cancer with radiographic and\u002For clinical evidence of advanced metastatic or unresectable disease.\n* HR+\u002FHER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.\n\nOR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.\n\n* Subject must have the CTC HER2, ER, PD-L1, and cfDNA\u002FRNA tests ordered during routine patient care.\n* Age \\> 18 years.\n\nExclusion Criteria:\n\n* Participant is pregnant.\n* Inability to provide blood samples based on the judgment of the treating physician.","ALL","18 Years",{"count":83,"type":84},187,"ESTIMATED","24 Months","OBSERVATIONAL","The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. The test consists of diagnostic CTC counts (enumeration) and expression of biomarkers Human Epidermal growth factor Receptor 2 (HER2), Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) and cell free DNA\u002FRNA (cfDNA\u002FRNA) analysis.",[89],"Metastatic Breast Cancer (MBC)",[91,92,93],"CTC","cfDNA","cfRNA","2026-03-16",{"date":96,"type":97},"2026-03-18","ACTUAL",{"date":99,"type":97},"2026-03-13",{"date":101,"type":84},"2028-10",{"name":5,"class":6},1]