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.
Men or women aged 18 and over
Biopsy proven invasive triple negative breast cancer (defined here as estrogen receptor <10%, progesterone receptor <10%, human epidermal growth factor receptor 2 (HER2) negative status, with HER2 status being defined as per ASCO/CAP guidelines)
T2-4/N0 (>2 cm primary breast cancer as assessed clinically or on imaging in the absence of nodal involvement) OR T1c-4/N1-3 disease (>10mm with fine needle aspirate or core biopsy confirming nodal involvement is required)
Residual disease (RCB 2 or 3) on surgical specimen after completion of neoadjuvant chemo(-immuno)therapy
Inability to provide informed consent. Participants who require translators are allowed to enroll
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)-
Pregnant patients are not permitted
Creatinine clearance <45 mL/min using the Cockcroft-Gault equation.
Parallel
ctDNA-guided imaging surveillance
Diagnostic testSerial 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 interventionStandard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.
Recruitment rate
Proportion of eligible patients approached who agree to participate
Proportion of randomized patients who complete 1 year of follow-up
Incidence of metastatic breast cancer
Incidence of radiographic metastatic disease among patients with positive ctDNA
Assessed by serial CT scans, MRI scans and bone scans, as previously described
Number and types of diagnostic and/or therapeutic interventions
Quality of life (EORTC QLQ BN20)
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This trial is not recruiting at the moment. You can still explore other options:
