[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629748":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":26,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":26},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Surveillance","EXPERIMENTAL","ctDNA-guided imaging surveillance, in addition to standard of care surveillance",[13,14],"Diagnostic Test: ctDNA-guided imaging surveillance","Other: Standard",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of care","ACTIVE_COMPARATOR","Standard of care surveillance",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","ctDNA-guided imaging surveillance","Serial ctDNA measurements post-operatively at time of randomization and every 3 months up to a year, with ctDNA positivity triggering additional imaging investigations (CT chest\u002Fabdomen\u002Fpelvis with contrast, bone scan, and MRI brain with contrast) every 3 months until detection of overt metastatic breast cancer; overt metastatic breast cancer will be treated as per standard of care.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard","Standard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.",[9,16],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Katarzyna Jerzak, MD, MSc, FRCPC","CONTACT","416-480-5248","katarzyna.jerzak@sunnybrook.ca",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr. Katarzyna Jerzak","Associate Professor","100629748",false,"NCT07478705","Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging","Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer (TNBC) Using Liquid Biopsy and Imaging: A Multi-Center Pilot Randomized Trial (EINSTEIN-TNBC)","EINSTEIN-TNBC","Inclusion Criteria:\n\n* Men or women aged 18 and over\n* Biopsy proven invasive triple negative breast cancer (defined here as estrogen receptor \\\u003C10%, progesterone receptor \\\u003C10%, human epidermal growth factor receptor 2 (HER2) negative status, with HER2 status being defined as per ASCO\u002FCAP guidelines)\n* T2-4\u002FN0 (\\>2 cm primary breast cancer as assessed clinically or on imaging in the absence of nodal involvement) OR T1c-4\u002FN1-3 disease (\\>10mm with fine needle aspirate or core biopsy confirming nodal involvement is required)\n* Residual disease (RCB 2 or 3) on surgical specimen after completion of neoadjuvant chemo(-immuno)therapy\n\nExclusion Criteria:\n\n* Inability to provide informed consent. Participants who require translators are allowed to enroll\n* Prior history of invasive breast cancer -Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the detection of BC recurrence on a liquid biopsy (patients with a history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma-in-situ of cervix are permitted to participate)-\n* Pregnant patients are not permitted\n* Creatinine clearance \\\u003C45 mL\u002Fmin using the Cockcroft-Gault equation.","ALL","18 Years",{"count":51,"type":52},30,"ESTIMATED","INTERVENTIONAL",[55],"NA","Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer, often with poor outcomes. Currently, follow-up for TNBC consists of physical exams and annual breast imaging, with additional scans only if symptoms appear. This approach may delay the detection of the cancer coming back until the disease is advanced.\n\nA promising new technique is the detection of circulating tumor DNA (ctDNA)-in the blood. Studies suggest ctDNA may identify cancer recurrence months before it becomes visible on scans or causes symptoms. However, it is unknown whether detecting recurrence earlier can actually help patients live longer or feel better.\n\nThe EINSTEIN-TNBC trial is a study aiming to evaluate the feasibility of ctDNA-guided surveillance for patients with TNBC after surgery.\n\nThirty participants will be randomized to either:\n\nStandard of care (routine physical exams and annual breast imaging), or Active surveillance (standard of care plus ctDNA testing, with imaging investigations if ctDNA is detected).\n\nThis study will assess the feasibility of conducting a ctDNA-based monitoring trial in this patient population.\n\nIf feasible, EINSTEIN-TNBC will lay the foundation for a larger future clinical trial to determine whether earlier detection of metastatic TNBC can improve survival and quality of life.",[58,59,60,61],"Triple Negative Breast Cancer","Surveillance","Recurrence","ctDNA",[61,58,59,60],"NOT_YET_RECRUITING","2026-03-13",{"date":66,"type":67},"2026-03-17","ACTUAL",{"date":69,"type":52},"2026-05-01",{"date":71,"type":52},"2029-05-01",{"name":5,"class":6}]