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 are willing to take part and have signed a consent form agreeing to join the study.
• Women aged 18 to 75 who have been diagnosed with triple-negative breast cancer (TNBC), confirmed through a tissue or cell sample, including those with low levels of hormone receptor expression (1%–10%).
• People whose breast cancer is considered high-risk because cancer has spread to the lymph nodes.
• People who are generally well enough to carry out daily activities, with only mild limitations at most (based on a standard doctor-assessed scale called ECOG, scored 0 or 1).
• People who agree to provide tumour tissue samples collected during surgery for testing purposes.
• People whose doctors expect them to survive for at least 3 months.
• People whose blood counts and organ function meet specific health thresholds — including healthy levels of white blood cells, platelets, red blood cells, liver enzymes, kidney function, and other blood markers — measured before starting treatment (confirm specific values with the trial site).
• Women who could become pregnant must use an approved form of contraception during the trial and for 3 months after treatment ends, and must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding.

Who may not be able to join:

• People who have an active autoimmune disease or a history of one (such as autoimmune hepatitis, lupus, or inflammatory bowel disease), though some milder or well-controlled conditions — such as vitiligo, well-managed thyroid conditions, or well-controlled type 1 diabetes — may still be eligible (confirm with trial site).
• People who have been taking immune-suppressing medications or high-dose steroid tablets within the 2 weeks before joining the trial.
• People who have had a serious allergic reaction to a monoclonal antibody medication in the past.
• People who previously had to stop taking an anti-PD-1 or anti-PD-L1 immunotherapy drug because of side effects.
• People with a known history of lung inflammation (interstitial lung disease or pneumonitis not caused by infection).
• People with known cancer spread to the brain, or those with symptoms that suggest possible brain involvement, unless brain scans have ruled it out.
• People who have had another type of cancer in the past, unless it was a skin cancer (non-melanoma type) or early-stage cervical cancer, or unless they have been cancer-free for at least 3 years.
• People with poorly controlled high blood pressure (above 140/90 mmHg despite medication), or a history of hypertensive crisis or related brain complications.
• People who have had unstable chest pain, a heart attack, significant heart failure, or a serious heart rhythm problem in the 6 months before joining, or those with reduced heart pumping function below a certain level (confirm with trial site).
• People currently on blood-thinning (anticoagulant or clot-dissolving) therapy, though low-dose aspirin or low-molecular-weight heparin for prevention may be allowed (confirm with trial site).
• People with fluid build-up around the lungs, abdomen, or heart that requires drainage, unless the condition has stabilised after drainage as assessed by the doctor.
• People who have had a blood clot, stroke, mini-stroke, or pulmonary embolism within the 6 months before joining.
• People who have had a serious blood vessel condition — such as an aortic aneurysm or arterial blood clot requiring surgery — within 6 months before starting the trial.
• People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the trial.
• People who have too much protein in their urine, above a level confirmed by a 24-hour urine test (confirm with trial site).
• People who have recently received radiotherapy, chemotherapy, surgery, or other cancer treatments and have not waited a sufficient amount of time before starting this trial, or whose side effects from previous treatment have not sufficiently resolved (confirm specific timeframes with trial site).
• People who have an active infection, an unexplained high fever in the 7 days before starting treatment, or a high white blood cell count.
• People with HIV infection, active hepatitis B (with a viral load above a certain level), or hepatitis C.
• People who have previously been treated with immune checkpoint inhibitor drugs such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies.
• People who have received a live vaccine within 4 weeks before starting the trial, or who may need one during the trial.
• Women who are pregnant or breastfeeding.
• People whose doctors identify any other medical, psychiatric, or personal circumstance that could affect the safety of taking part or the reliability of the study results.

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