Early Stage Triple Negative ER Low Breast CancerPhase 2OZM-034NCT06710197
IL-1 Inhibition in Early TNBC
A Phase 2 study testing Anakinra (Kineret®) in people with Early Stage Triple Negative ER Low Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Triple Negative ER Low Breast Cancer
- What is being tested?
- Anakinra (Kineret®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2025to 12 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in this study, patients must fulfill all the following criteria:
- Age > 18 years
- Histologically confirmed non-metastatic invasive adenocarcinoma of the breast meeting one of the following criteria:
- Clinical stage T1a/b N0 TNBC ii. Clinical stage T1a/b N0 ER-low (1-9%)
- Not planned for neoadjuvant chemotherapy
Who cannot join
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study.
- Male Gender
- HER2 positive breast cancer
- Second primary cancer
- Multifocal early breast cancer
- Pre-existing inflammatory arthritis
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- Pregnancy or lactating.
- Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L
- ECOG≥2
- Clinically significant bacterial, fungal, parasitic or viral infection, which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
- Known active hepatitis A, B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (i.e., hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
- Primary immunodeficiency such as X-linked agammaglobulinemia or common variable immunodeficiency.
- Active and inactive ('latent') tuberculosis infection or suspicion of active tuberculosis. If no suspicion of active tuberculosis, testing is not required.
- Use of glucocorticoids above the equivalent of 10 mg of prednisone daily within 4 weeks prior to treatment with Anakinra.
- Major surgery within 4 weeks prior to treatment.
- History of malignancy in the past 3 years except for treated, early-stage squamous or basal cell carcinoma of the skin or carcinoma-in-situ of the cervix.
- History or current diagnosis of uncontrolled or significant cardiac disease, including any of the following: a. myocardial infarction within last 6 months. b. uncontrolled congestive heart failure. c. unstable angina within last 6 months. d. exertional angina. e. clinically significant (symptomatic) cardiac arrhythmias (e.g., bradyarrhythmia, sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Presence of moderate or severe renal function impairment (estimated creatinine clearance <60 mL/min/1.73m2).
- Patients with mild, moderate, or severe hepatic impairment or inadequate liver function defined by any of direct bilirubin, alanine amino transferase (ALT), or aspartate aminotransferase (AST)>2.5 x upper limit of normal (ULN). Patients with Child-Pugh score >5 are also excluded.
- Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days of screening or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
- Significant concurrent, uncontrolled medical condition which, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- Known hypersensitivity to E-coli derived proteins, Anakinra or any component of the product.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network-Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
About this study
Official title: IL-1 Inhibition for Patients With Early Stage Triple Negative and ER-low Breast Cancer: a Window-of-opportunity Study
This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive). Key immune biomarkers (TILs, TAMs, NK cells, IL1[beta] and inflammasome component expression) will be evaluated at baseline and following 14 days of IL-1 antagonist therapy (Anakinra) using paired tissue specimens.
- Being tested
- Anakinra (Kineret®)
- Keywords
- WOO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra (Kineret®)Drug
100 mg/daily subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Anakinra SC injection 100mg daily x 14 days Receives: Drug: Anakinra (Kineret®) |
| Group 2 | No intervention | Patients will receive standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the changes in the breast cancer TME in paired patient samples (core biopsy and surgical specimen) before and after 14 days of treatment with the IL-1 receptor antagonist, Anakinra.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start5 Mar 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Why it stopped: Terminated with sponsor-investigator agreement due to extended period without enrollment and the absence of foreseeable participant accrual. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Triple Negative ER Low Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive \[1-9%\]). Key immune biomarkers (TILs, TAMs, NK cells, IL-1β and inflammasome component expression) will be evaluated at baseline and following 14 days of IL-1 antagonist therapy (Anakinra) using paired tissue specimens. A total of 50 patients will be recruited across 2-5 institutions, randomized 4:1 to treatment (n=40) versus control (n=10).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710197
- Sponsor's protocol ID
- WOO-11-2023
- Acronym
- OZM-034
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-1 Inhibition for Patients With Early Stage Triple Negative and ER-low Breast Cancer: a Window-of-opportunity Study
- ClinicalTrials.gov ID
- NCT06710197
- Acronym / sponsor ID
- OZM-034 / WOO-11-2023
- Keywords
- WOO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated with sponsor-investigator agreement due to extended period without enrollment and the absence of foreseeable participant accrual. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 29 Nov 2024 (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.
This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive). Key immune biomarkers (TILs, TAMs, NK cells, IL1[beta] and inflammasome component expression) will be evaluated at baseline and following 14 days of IL-1 antagonist therapy (Anakinra) using paired tissue specimens.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will examine changes in the tumor microenvironment (TME) induced by 14 days of pre-operative IL-1-inhibiting therapy among patients with early breast cancer (including TNBC and ER-low positive [1-9%]). Key immune biomarkers (TILs, TAMs, NK cells, IL-1β and inflammasome component expression) will be evaluated at baseline and following 14 days of IL-1 antagonist therapy (Anakinra) using paired tissue specimens. A total of 50 patients will be recruited across 2-5 institutions, randomized 4:1 to treatment (n=40) versus control (n=10).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Anakinra (Kineret®)Anakinra SC injection 100mg daily x 14 days |
| Group 2 | No intervention | –Patients will receive standard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For inclusion in this study, patients must fulfill all the following criteria:
Key exclusion criteria (23 listed)
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study.
- Male Gender
- HER2 positive breast cancer
- Second primary cancer
- Multifocal early breast cancer
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 |
|---|---|---|
| Anakinra (Kineret®)100 mg/daily subcutaneously | Drug | Group 1 |
Primary outcome
To determine the changes in the breast cancer TME in paired patient samples (core biopsy and surgical specimen) before and after 14 days of treatment with the IL-1 receptor antagonist, Anakinra.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Early Stage Triple Negative ER Low Breast Cancer
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DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
Triple Negative Breast Cancer, HER2-negative Breast Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra (Kineret®) in people with Early Stage Triple Negative ER Low Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 23 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: withdrawn, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the changes in the breast cancer TME in paired patient samples (core biopsy and surgical specimen) before and after 14 days of treatment with the IL-1 receptor antagonist, Anakinra. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.