Clinical trial · Interventional
Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ctDNA | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Surveillance | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA-guided imaging surveillance | Diagnostic Test | — | UNRESOLVED |
| Standard | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Surveillance
- description
- ctDNA-guided imaging surveillance, in addition to standard of care surveillance
- interventionNames
- Diagnostic Test: ctDNA-guided imaging surveillance
- Other: Standard
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Standard of care surveillance
- interventionNames
- Other: Standard
Primary outcomes (3)
- measure
- Recruitment rate
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (3)
- BACKGROUNDNader-Marta G, Monteforte M, Agostinetto E, Cinquini M, Martins-Branco D, Langouo M, Llombart-Cusac A, Cortes J, Ignatiadis M, Torri V, Apolone G, Cappelletti V, Pruneri G, de Azambuja E, Di Cosimo S. Circulating tumor DNA for predicting recurrence in patients with operable breast cancer: a systematic review and meta-analysis. ESMO Open. 2024 Mar;9(3):102390. doi: 10.1016/j.esmoop.2024.102390. Epub 2024 Mar 10. PMID 38460249
- BACKGROUNDPusztai L, Denkert C, O'Shaughnessy J, Cortes J, Dent R, McArthur H, Kummel S, Bergh J, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Zhu Y, Pan W, Tryfonidis K, Schmid P. Event-free survival by residual cancer burden with pembrolizumab in early-stage TNBC: exploratory analysis from KEYNOTE-522. Ann Oncol. 2024 May;35(5):429-436. doi: 10.1016/j.annonc.2024.02.002. Epub 2024 Feb 17. PMID 38369015
- BACKGROUNDSchmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651. PMID 35139274