Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:21 PM
Study NCT ID:
NCT07478705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EINSTEIN-TNBC
Brief 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.
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.
Detailed Description:
Background:
Triple-negative breast cancer (TNBC) is associated with poor clinical outcomes. In patients with stage II-III TNBC treated with neoadjuvant therapy in the KEYNOTE-522 trial, almost one-third of patients with residual disease died at 5 years. Yet, standard-of-care (SOC) surveillance after curative therapy consists of routine breast imaging and physical examination, with additional imaging performed only upon development of symptoms suggestive of disease recurrence. Given the ability of circulating tumor DNA (ctDNA) to detect metastatic recurrence at its earlier stages, even prior to detection using conventional imaging, it is possible that early detection and intervention for molecular relapse of TNBC may improve patients' outcomes. This pilot trial evaluates the feasibility of a future phase III randomized controlled trial (RCT), which would evaluate whether ctDNA-based surveillance and subsequent early intervention may improve patients' outcomes including overall survival (OS).
Methods:
This is a multi-center, pilot randomized trial conducted at 3 Canadian cancer centers: Sunnybrook Odette Cancer Centre, Princess Margaret Cancer Centre, and William Osler Health System. Inclusion Criteria: 1) Age ≥18; 2) Biopsy-proven invasive TNBC; 3) T2-4/N0 OR T1c-4/N1-3 disease at initial diagnosis; 4) Residual disease (RCB 2 or 3) after curative-intent neoadjuvant chemo(-immuno)therapy. Exclusion Criteria: 1) Inability to provide informed consent; 2) Prior invasive breast cancer; 3) Another malignancy which may interfere with assessment of clinical outcomes; 4) Current pregnancy; 5) Creatinine clearance \<45 mL/min. Post-operatively, participants are randomized 1:1 to 'active surveillance' and SOC surveillance. 'Active surveillance' consists of serial ctDNA measurements (specific assay currently embargoed but will be presented) every 3 months for 1 year post-operatively; ctDNA positivity will trigger imaging investigations (i.e. CT chest/abdomen/pelvis with contrast, bone scan, and MRI brain with contrast) every 3 months until detection of overt MBC. Overt MBC will be treated as per SOC. Primary endpoints: 1) Recruitment rate; 2) Proportion of eligible patients approached who agree to participate; 3) Proportion of randomized patients who complete 1 year of follow-up. Secondary Endpoints: 4) MBC incidence; 5) Correlation of ctDNA findings with imaging results; 6) Number and types of diagnostic and/or therapeutic interventions; 7) Quality of life (EORTC QLQ BN20); 8) Patient anxiety (NCI PRO-CTCAE); 9) ctDNA turnaround time; 10) invasive disease-free survival (iDFS); 11) OS; 12) Perceptions of medical oncologists regarding their experience using ctDNA as a monitoring tool.
Triple-negative breast cancer (TNBC) is associated with poor clinical outcomes. In patients with stage II-III TNBC treated with neoadjuvant therapy in the KEYNOTE-522 trial, almost one-third of patients with residual disease died at 5 years. Yet, standard-of-care (SOC) surveillance after curative therapy consists of routine breast imaging and physical examination, with additional imaging performed only upon development of symptoms suggestive of disease recurrence. Given the ability of circulating tumor DNA (ctDNA) to detect metastatic recurrence at its earlier stages, even prior to detection using conventional imaging, it is possible that early detection and intervention for molecular relapse of TNBC may improve patients' outcomes. This pilot trial evaluates the feasibility of a future phase III randomized controlled trial (RCT), which would evaluate whether ctDNA-based surveillance and subsequent early intervention may improve patients' outcomes including overall survival (OS).
Methods:
This is a multi-center, pilot randomized trial conducted at 3 Canadian cancer centers: Sunnybrook Odette Cancer Centre, Princess Margaret Cancer Centre, and William Osler Health System. Inclusion Criteria: 1) Age ≥18; 2) Biopsy-proven invasive TNBC; 3) T2-4/N0 OR T1c-4/N1-3 disease at initial diagnosis; 4) Residual disease (RCB 2 or 3) after curative-intent neoadjuvant chemo(-immuno)therapy. Exclusion Criteria: 1) Inability to provide informed consent; 2) Prior invasive breast cancer; 3) Another malignancy which may interfere with assessment of clinical outcomes; 4) Current pregnancy; 5) Creatinine clearance \<45 mL/min. Post-operatively, participants are randomized 1:1 to 'active surveillance' and SOC surveillance. 'Active surveillance' consists of serial ctDNA measurements (specific assay currently embargoed but will be presented) every 3 months for 1 year post-operatively; ctDNA positivity will trigger imaging investigations (i.e. CT chest/abdomen/pelvis with contrast, bone scan, and MRI brain with contrast) every 3 months until detection of overt MBC. Overt MBC will be treated as per SOC. Primary endpoints: 1) Recruitment rate; 2) Proportion of eligible patients approached who agree to participate; 3) Proportion of randomized patients who complete 1 year of follow-up. Secondary Endpoints: 4) MBC incidence; 5) Correlation of ctDNA findings with imaging results; 6) Number and types of diagnostic and/or therapeutic interventions; 7) Quality of life (EORTC QLQ BN20); 8) Patient anxiety (NCI PRO-CTCAE); 9) ctDNA turnaround time; 10) invasive disease-free survival (iDFS); 11) OS; 12) Perceptions of medical oncologists regarding their experience using ctDNA as a monitoring tool.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: