IL-1 Inhibition in Early TNBC

IL-1 Inhibition for Patients With Early Stage Triple Negative and ER-low Breast Cancer: a Window-of-opportunity Study

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06710197

Acronym

OZM-034

Enrollment

Registered

2024-11-29

Start date

2025-03-05

Completion date

2026-02-12

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Stage Triple Negative ER Low Breast Cancer

Keywords

WOO

Brief 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). 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.

Interventions

DRUGAnakinra (Kineret®)

100 mg/daily subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention 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).

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* For inclusion in this study, patients must fulfill all the following criteria: 1. Age \> 18 years 2. Histologically confirmed non-metastatic invasive adenocarcinoma of the breast meeting one of the following criteria: i. Clinical stage T1a/b N0 TNBC ii. Clinical stage T1a/b N0 ER-low (1-9%) 3. Not planned for neoadjuvant chemotherapy

Exclusion criteria

Patients who satisfy any of the following

Design outcomes

Primary

Measure	Time frame
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.	2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026