Clinical Research Directory
Browse clinical research sites, groups, and studies.
Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging
Sponsor: Sunnybrook Health Sciences Centre
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-05-01
Completion Date
2029-05-01
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
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/abdomen/pelvis 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.
Standard
Standard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.