Phase 3 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 whose breast cancer has been confirmed as triple-negative (TNBC) through a tissue or cell sample — meaning the cancer tests negative for oestrogen receptors, progesterone receptors, and HER2.
• People whose cancer falls within certain size and spread categories (involving the breast and nearby lymph nodes, but not spread to distant parts of the body — confirm specific staging details with the trial site).
• People who are generally well enough to carry out daily activities with little to no limitation (based on a standard health scoring scale).
• People whose blood counts are within acceptable ranges, including healthy levels of red blood cells, white blood cells, and platelets, with no blood transfusions in the past 3 weeks or certain blood-boosting treatments in the past 2 weeks.
• People whose liver is functioning adequately, based on blood test results falling within acceptable ranges.
• People whose blood clotting function is within acceptable limits (those on blood-thinning medication may still be considered but would require close monitoring — confirm with the trial site).
• People whose kidneys are functioning adequately, based on blood test results or a calculated kidney function score.
• People whose heart's pumping strength (left ventricular ejection fraction) is at least 50%, as measured by a heart scan.
• People with no serious heart disease or significant irregular heart rhythms.
• Women of childbearing potential (generally aged 15–49) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants who could potentially have children must agree to use effective contraception throughout the study and for 3 months after finishing treatment.
• People who have read, understood, and voluntarily signed a consent form agreeing to take part.

Who may not be able to join:

• People who have a history of mental illness or who are diagnosed with a mental health condition at the time of enrolment.
• People who have difficulty communicating clearly due to confusion, speech difficulties, intellectual disability, or similar reasons.
• People whose cancer-related pain is not well controlled.
• People who are currently taking part in another clinical trial at the same time.
• People with active or past autoimmune diseases or immune system deficiencies, including conditions such as lupus, rheumatoid arthritis, multiple sclerosis, myasthenia gravis, inflammatory bowel disease, Sjögren's syndrome, or similar conditions.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, a type of lung inflammation called organising pneumonia, drug-related lung damage, or unexplained pneumonia — or those whose screening chest scan shows signs of active pneumonia.
• People with active tuberculosis affecting the lungs.
• People who have experienced serious heart or cardiovascular events in the 3 months before the study, such as a heart attack, stroke, unstable irregular heartbeat, or unstable chest pain — or those with moderate-to-severe heart failure.
• People who have had a major surgical procedure (other than a diagnostic procedure) within 4 weeks before starting the study, or who are expected to need major surgery during the study.
• People who have had another cancer (other than breast cancer) within the past 5 years — with some exceptions for certain low-risk, highly treatable cancers such as some skin cancers, cervical carcinoma in situ, ductal carcinoma in situ, or early-stage uterine cancer (confirm with the trial site).
• People who had a serious infection in the 4 weeks before starting the study, including infections serious enough to require hospitalisation, blood infections, or severe pneumonia.
• People who have previously received a transplant of stem cells or a solid organ from another person.
• People with other significant medical conditions, abnormal test results, or health factors that the trial site determines could make participation unsafe or affect the reliability of the results.

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