Testing Group 1-Isunakinra for triple-negative breast cancer (TNBC)

Exclusion

• −Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product
• −Luminal A/B and HER2 positive breast cancer
• −Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• −Male Gender
• −Multifocal early breast cancer
• −History of invasive malignancy ≤5 years prior to signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• −Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor
• −Participated in an interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study with an investigational compound or device within 4 weeks of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → for this study
• −Pre-existing inflammatory arthritis
• −Has received a live vaccine within 30 days of the first dose of study treatment
• −Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
• −Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• −Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• −Has an active infection requiring systemic therapy
• −Has significant cardiovascular disease
• −Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)
• −Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L
• −History of stroke or intracranial hemorrhage within 6 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −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 (total bilirubin \> 23 umol/L, serum albumin \< 35 g/L, INR \> 1.70)
• −Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study
• −Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months