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
Study ID
NCT07478705
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ctDNA-guided imaging surveillance — DIAGNOSTIC_TEST
    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 — OTHER
    Standard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.

Study Details

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.

Key Dates

First listed
Mar 17, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Active Surveillance
    ctDNA-guided imaging surveillance, in addition to standard of care surveillance
  • Active Comparator: Standard of care
    Standard of care surveillance

Primary Outcome Measure

Recruitment rate [ Time Frame: 24 months ]

Central Contacts

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