Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give written consent and are willing and able to follow all study-related procedures
• People who are 18 years of age or older, of any gender
• People with a diagnosis of metastatic triple negative or hormone-resistant, HER2-negative breast cancer that has been confirmed by a tissue sample at some point during the course of the disease (Phase I only)
• People who have a life expectancy of at least 6 months (Phase I only)
• People whose most recent chemotherapy treatment was completed at least 3 weeks before starting the study drug, with no limit on how many prior treatments there have been; for hormone-sensitive tumours, at least one prior treatment must have included hormone therapy; a drug called capecitabine is allowed only if it was not part of the most recent treatment before joining (Phase I only)
• People with a confirmed diagnosis of triple negative breast cancer (TNBC), based on specific tissue testing results (Phase II and Parallel Baseline Arm only)
• People with a confirmed diagnosis of stage I, II, or III breast cancer who did not have a complete response after pre-surgery treatment, meaning some invasive cancer was still found in the removed breast tissue or lymph nodes (Phase II and Parallel Baseline Arm only)
• People who have not received any systemic (whole-body) treatment for breast cancer other than their pre-surgery treatment, and whose pre-surgery treatment did not include capecitabine or sarilumab (Phase II and Parallel Baseline Arm only)
• People whose general physical functioning is rated at a certain level by their doctor (ECOG Performance Status of 2 or lower, meaning they are able to carry out some daily activities) (confirm with trial site)
• People whose blood counts and organ function meet specific minimum levels, including adequate white blood cells, platelets, haemoglobin, liver function, and kidney function (confirm with trial site for exact values)
• Women who could become pregnant must agree to use a highly effective form of contraception throughout the study and for at least 24 weeks after the last dose of the study drug
• Men whose partners could become pregnant must agree to use an approved form of contraception throughout the study and for at least 24 weeks after the last dose of the study drug

Who may not be able to join:

• People who are unwilling or unable to use an acceptable method of contraception for the entire study period and for at least 24 weeks after the last dose of the study drug
• Women who are currently pregnant or breastfeeding
• People with any other medical condition, physical finding, or laboratory result that the treating doctor believes would make the study treatment unsafe or could affect the study results
• People with a current hepatitis B infection (prior vaccination is acceptable) (Phase I and Phase II only)
• People with a known history of tuberculosis infection (Phase I and Phase II only)
• People with a history of diverticulitis (a condition affecting the bowel) (Phase I and Phase II only)
• People who have received a live vaccine within 30 days before starting the study treatment — this includes vaccines such as MMR, chickenpox, yellow fever, rabies, BCG, typhoid, and nasal flu spray; standard injected flu vaccines are generally allowed (Phase I and Phase II only)
• People with a history of another cancer that their oncologist considers to carry a higher risk of return or death than the cancer being studied in this trial
• People who are currently in prison or are being held in a facility against their will
• People who are being legally required to receive treatment for a mental health or physical health condition
• People who are unlikely to be able to follow the study procedures or attend follow-up appointments

Important: Always verify eligibility with the trial site directly before applying.