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.
• 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:
‣ i. Clinical stage T1a/b N0 TNBC ii. Clinical stage T1a/b N0 ER-low (1-9%)
⁃ Not planned for neoadjuvant chemotherapy