[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659226":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":74,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":18,"enrollmentInfo":91,"targetDuration":18,"studyType":94,"phases":18,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":103,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"To Assess the performance of the baseline PERDI score","Assessment of the performance of the baseline PERDI score, derived from plasma patients collected prior to the start of their second-line endocrine therapy (2L ET) using an epigenomics-based cell-free DNA (cfDNA) profiling assay, in predicting Progression-free survival (PFS).","From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year",[14],{"measure":15,"description":16,"timeFrame":17},"Assessment of the baseline modified PERDI score","Preform a prospective cross-study meta-analysis of both PERDI and modifies PERDI. Progression-free survival (PFS) will be compared between modified PERDI-positive and negative derived from plasma collected at the start of second line therapy using epigenomics- based cfDNA profiling assay.","6 months or 1 year after start 2L therapy",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"CASE_ONLY","PROSPECTIVE","This prospective observational study will enroll up to 200 patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment. The goal is to evaluate whether a blood-based biomarker, called the PERDI score, can predict how well patients respond to a second line hormone therapy.\n\nParticipants will provide a blood sample before starting treatment, with optional additional samples collected during treatment or at disease progression. Researchers will compare the blood test results with clinical outcomes, including how long the cancer remains under control, to determine whether the PERDI score can help identify patients who are most likely to benefit from treatment.\n\nThe study will be conducted across multiple sites within a single institution and will run for approximately 18 months, including a 12-month enrollment period and 6 months of follow-up. Findings from this study may help support more personalized treatment decisions and improve outcomes for patients with advanced breast cancer.","All patients with metastatic breast cancer refer to UPMC all sites",[25],{"label":26,"type":18,"description":27,"interventionNames":18},"breast cancer stage IV patients","ER+ breast cancer stage IV patients after progression on first line treatment and will continue treatment with second line endocrine therapy",[29],{"name":30,"affiliation":5,"role":31},"Marjia Balic, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Setareh Sharzehi, MD, PhD, MS","CONTACT","(313) 452-3013","sharzehis@upmc.edu",{"name":30,"role":35,"phone":18,"phoneExt":18,"email":39},"balicm@upmc.edu",[41],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"UPMC\u002FMagee Hospital","Pittsburgh","Pennsylvania","15213","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-79.99589,40.44062,{"lat":52,"lon":51},[55,57,59,61,64,66,68,70,72],{"name":56,"role":35,"phone":36,"phoneExt":18,"email":37},"Setareh Sharzehi Sharzehi, MD, PhD",{"name":58,"role":35,"phone":18,"phoneExt":18,"email":39},"Marjia Balic, MD,PHD",{"name":60,"role":31,"phone":18,"phoneExt":18,"email":18},"Marjia Balic, MD,PhD",{"name":62,"role":63,"phone":18,"phoneExt":18,"email":18},"Julia Foldi, MD, PhD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":18,"phoneExt":18,"email":18},"Adam Brufsky, MD",{"name":67,"role":63,"phone":18,"phoneExt":18,"email":18},"Charles Geyer, MD",{"name":69,"role":63,"phone":18,"phoneExt":18,"email":18},"Vikram Gorantla, MD",{"name":71,"role":63,"phone":18,"phoneExt":18,"email":18},"Monica Molhatra, MD",{"name":73,"role":63,"phone":18,"phoneExt":18,"email":18},"Priya Rastogi, MD",{"type":31,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marija Balic, MD PhD","Professor of Medicine",[78],{"name":79,"class":80},"Precede Biosciences","UNKNOWN","100659226","blood-biomarkers-for-breast-cancer-treatment-response-100659226",false,"NCT07860866","Blood Biomarkers for Breast Cancer Treatment Response","Prospective Plasma Biomarker Study to Predict 2nd Line Endocrine Therapy Response in ER+ Metastatic Breast Cancer (TrackER)","TrackER","Inclusion Criteria:\n\n1. Patients must be ≥18 years of age\n2. Cytologically or histologically confirmed invasive breast cancer that is:\n\n   1. Clinical stage IV\n   2. HR positive\n   3. Progressing on first line treatment\n3. ECOG 0-2\n4. Locally assessed ER+.\n5. Locally assessed HER2-negative (IHC 2+\u002FFISH-negative or IHC 0 or 1+ \u002Feither FISH-negative or untested).\n6. No prior chemotherapy\n7. Must have the ability to understand and the willingness to sign a written informed consent document.\n8. Must be willing to provide serial blood samples for the study.\n\nExclusion Criteria:\n\n1\\. Medical condition or social situation that may preclude adherence to the protocol.","ALL","18 Years",{"count":92,"type":93},200,"ESTIMATED","OBSERVATIONAL","This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work. It follows patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment.\n\nResearchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time. By comparing blood test results with patient outcomes, the study aims to identify biomarkers that can predict which patients are most likely to benefit from treatment.",[97,98],"Breast Cancer (Advanced\u002FMetastatic)","ER Positive",[100,101,102],"ER+ metastatic Breast Cancer","Plasma Biomarker","2nd line Endocrine therapy","NOT_YET_RECRUITING","2026-09-30",{"date":106,"type":107},"2026-10-06","ACTUAL",{"date":109,"type":93},"2026-11-01",{"date":111,"type":93},"2028-05-01",{"name":5,"class":6},1]