Clinical Trial

Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging

Study acronym: EINSTEIN-TNBC
Not Yet Recruiting
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Summary
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. A 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. The EINSTEIN-TNBC trial is a study aiming to evaluate the feasibility of ctDNA-guided surveillance for patients with TNBC after surgery. Thirty participants will be randomized to either: Standard 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). This study will assess the feasibility of conducting a ctDNA-based monitoring trial in this patient population. If 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.
Trial Details
NCT Number NCT07478705
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions Triple Negative Breast Cancer, Surveillance, Recurrence, ctDNA
Enrollment 30 participants
Start Date 2026-05-01
Primary Completion 2029-05-01 (estimated)
Study Completion 2029-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-17