Triple Negative Breast CancerEINSTEIN-TNBCNCT07478705
Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging
A study testing ctDNA-guided imaging surveillance and Standard in people with Triple Negative Breast Cancer and Surveillance, run by Sunnybrook Health Sciences Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Surveillance, Recurrence
- What is being tested?
- ctDNA-guided imaging surveillance and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Triple Negative Breast Cancer, Surveillance, Recurrence, ctDNA
- Being tested
- ctDNA-guided imaging surveillance, Standard
- Keywords
- ctDNA, Triple Negative Breast Cancer, Surveillance, Recurrence
- Medical subject headings
- Triple Negative Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA-guided imaging surveillanceDiagnostic 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.
StandardOther
Standard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Experimental | ctDNA-guided imaging surveillance, in addition to standard of care surveillance Receives: Diagnostic Test: ctDNA-guided imaging surveillance; Other: Standard |
| Standard of care | Active comparator | Standard of care surveillance Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: 24 months
Proportion of eligible patients approached who agree to participate
Measured: 24 months
Proportion of randomized patients who complete 1 year of follow-up
Measured: 36 months
Secondary outcomes (9)
Incidence of metastatic breast cancer
Measured: 36 months
Incidence of radiographic metastatic disease among patients with positive ctDNA
Assessed by serial CT scans, MRI scans and bone scans, as previously described
Measured: 36 months
Number and types of diagnostic and/or therapeutic interventions
Measured: 36 months
Quality of life (EORTC QLQ BN20)
Measured: 36 months
Patient anxiety (NCI PRO-CTCAE)
Measured: 36 months
ctDNA turnaround time
Measured: 36 months
Invasive disease-free survival
Measured: 36 months
Overall survival
Measured: 36 months
Perceptions of medical oncologists regarding their experience using ctDNA as a monitoring tool
This will be evaluated by the Acceptability of Intervention Measure (AIM) validated tool
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478705
- Sponsor's protocol ID
- EINSTEIN-TNBC
- Acronym
- EINSTEIN-TNBC
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nader-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.
PubMed 38460249Pusztai 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.
PubMed 38369015Schmid 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.
PubMed 35139274
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07478705
- Acronym / sponsor ID
- EINSTEIN-TNBC / EINSTEIN-TNBC
- Conditions
- Triple Negative Breast Cancer, Surveillance, Recurrence, ctDNA
- Keywords
- ctDNA, Triple Negative Breast Cancer, Surveillance, Recurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Experimental | Diagnostic Test: ctDNA-guided imaging surveillance, Other: StandardctDNA-guided imaging surveillance, in addition to standard of care surveillance |
| Standard of care | Active comparator | Other: StandardStandard of care surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNA-guided imaging surveillanceSerial 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. | Diagnostic test | Active Surveillance |
| StandardStandard of care surveillance consists of history and physical examination every 3 months, and routine breast imaging. | Other | Active Surveillance, Standard of care |
Primary outcome
Recruitment rate
Time frame: 24 months
Proportion of eligible patients approached who agree to participate
Time frame: 24 months
Proportion of randomized patients who complete 1 year of follow-up
Time frame: 36 months
9 secondary outcomes
Incidence of metastatic breast cancer
Time frame: 36 months
Incidence of radiographic metastatic disease among patients with positive ctDNA
Time frame: 36 months
Number and types of diagnostic and/or therapeutic interventions
Time frame: 36 months
Quality of life (EORTC QLQ BN20)
Time frame: 36 months
Patient anxiety (NCI PRO-CTCAE)
Time frame: 36 months
ctDNA turnaround time
Time frame: 36 months
Invasive disease-free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Perceptions of medical oncologists regarding their experience using ctDNA as a monitoring tool
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 38460249Nader-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.
- Background: PubMed 38369015Pusztai 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.
- Background: PubMed 35139274Schmid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ctDNA-guided imaging surveillance and Standard in people with Triple Negative Breast Cancer and Surveillance, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Jerzak, MD, MSc, FRCPC (416-480-5248, katarzyna.jerzak@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07478705, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.