Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from 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 have given voluntary written consent to take part in the study
• People aged 18 to 70 years old (based on the age of the person signing the consent form)
• People who have been confirmed by tissue or cell testing to have advanced triple-negative breast cancer (TNBC) that has either spread to other parts of the body or has come back in a way that cannot be treated with surgery
• People whose tumor tissue has tested positive for a protein called PD-L1, with a score of 1 or higher on a specific measurement called CPS
• People who have already completed 6 cycles of a standard first-line treatment combining immunotherapy with chemotherapy, or immunotherapy with a type of drug called an ADC, with the last dose given no more than 28 days before joining the trial
• People whose cancer responded to or remained stable during those 6 cycles of treatment, as measured by standard assessment guidelines (RECIST v1.1)
• People who are planning to continue receiving immunotherapy
• People who are generally well enough to carry out basic daily activities, based on a standard medical scoring system (ECOG score of 0 or 1)
• People whose life expectancy is more than 12 weeks
• People whose organs (such as kidneys, liver, and bone marrow) are functioning at an adequate level (confirm specific values with the trial site)
• People who do not have mental or intellectual difficulties that would affect their participation
• People who are willing and able to follow the trial schedule and requirements throughout the study
• Women who could become pregnant must agree to use highly effective contraception starting at least 7 days before the first dose and continuing until 24 weeks after the last dose, and must have a negative pregnancy blood test within 7 days before the first dose

Who may not be able to join:

• People who have brain or membrane (meningeal) metastases that have not yet been treated
• People who have had another cancer in the past 5 years that is still active or growing (except certain well-controlled skin cancers or early-stage cancers that have been fully treated)
• People who have serious non-cancer illnesses that could affect their safety or ability to follow the trial
• People who currently have an active infection
• People who are already receiving other cancer treatments or taking part in another interventional clinical trial
• People who have a type of breast cancer called inflammatory breast cancer
• People who have dementia, intellectual disability, or a mental health condition that would prevent them from understanding and signing the consent form
• People who have had allergic reactions to any of the study drugs, or for whom those drugs are otherwise medically unsuitable
• People who currently have or have a history of autoimmune diseases (conditions where the immune system attacks the body)
• People who have significant heart problems, including heart failure at a certain level of severity, unstable chest pain (angina), a heart attack within the past year, or serious irregular heartbeats that require treatment
• People who are experiencing ongoing side effects of grade 3 or higher from previous cancer treatments that would make continuing on maintenance therapy unsafe
• People who have a weakened immune system, including those who are HIV-positive, have active hepatitis B or C, have other immune deficiency conditions, or have had an organ or stem cell transplant
• People who have received a live vaccine within 4 weeks before starting the study drugs, or who plan to receive one during the trial
• People who have previously been treated with certain chemotherapy drugs called topoisomerase I inhibitors (such as irinotecan or topotecan), or who have a known allergy to these drugs
• People who have been taking high-dose steroid tablets (above the equivalent of 10 mg per day of prednisone) within 14 days before starting the study, or who plan to take them long-term during the trial (some short-term or low-dose steroid use may be allowed — confirm with the trial site)
• People who have needed or plan to need immune-suppressing medications within 14 days before or during the trial
• Women who are pregnant or breastfeeding, or women who could become pregnant but are not willing to use contraception
• People who are unlikely to be available for follow-up appointments during the trial
• People whom the trial doctors consider unsuitable for any other medical or practical reason

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