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

NCT07478705 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

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/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.

OTHER

Standard

Standard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-05-01
Completion
2029-05-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478705 on ClinicalTrials.gov