IL-1 Inhibition in Early TNBC

NCT06710197 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: WOO-11-2023
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Triple Negative ER Low Breast Cancer

Keywords

WOO

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Anakinra SC injection 100mg daily x 14 days

Drug: Anakinra (Kineret®)

Group 2

NO INTERVENTION

Patients will receive standard of care treatment

Interventions

Anakinra (Kineret®) DRUG

100 mg/daily subcutaneously

Group 1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In this study, we will enroll women with early TNBC or ER low (1-9%) breast cancer with lesions that clinically measure up to 1cm in size (T1a/T1b), or lesions that are between 1 and \<2cm (T1c) with no clinical evidence of lymph node involvement who are not planned for neoadjuvant chemotherapy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• 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%)
• Not planned for neoadjuvant chemotherapy

You may not qualify if:

• Male Gender
• HER2 positive breast cancer
• Second primary cancer
• Multifocal early breast cancer
• Pre-existing inflammatory arthritis
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network-Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: March 5, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)