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:

• Women aged 18 years or older and younger than 75 years
• People who have been diagnosed with triple-negative breast cancer (TNBC) confirmed through a tissue or cell sample, where specific lab tests show low or no estrogen receptor, progesterone receptor, or HER2 protein activity
• People whose cancer has been tested for certain genetic subtypes, and for protein markers called PD-L1 and TMB
• People who are planned to have breast-conserving treatment after mastectomy, and who meet at least one of these conditions: the main tumour is 5cm or larger, or the cancer has grown into the skin or chest wall; or 4 or more underarm lymph nodes are affected; or 1–3 lymph nodes are affected in an earlier stage (T1–T2); or a full mastectomy with lymph node removal was done in stage T1–T2 with positive lymph nodes (confirm with trial site for exact surgical circumstances)
• People whose blood and organ function results fall within the ranges required by the trial, including adequate counts for white blood cells, platelets, and haemoglobin, as well as acceptable liver, kidney, and albumin levels
• People whose heart electrical reading (ECG) shows a QT interval measurement below a specific threshold
• Women who could potentially become pregnant must have a negative pregnancy test within 28 days before joining, and all participants of reproductive age must agree to use effective contraception during the study and for 90 days after the last dose
• People who are willing and able to provide written informed consent and follow the study requirements

Who may not be able to join:

• People who have another cancer that is currently growing or has needed active treatment (note: certain skin cancers or localised cancers that have been successfully treated may still be eligible — confirm with trial site)
• People who already have clear signs of cancer that has spread to other parts of the body at the time of diagnosis
• People who have previously been treated with certain immunotherapy drugs that target PD-1 or PD-L1, or who have had a serious allergic or hypersensitivity reaction to similar types of antibody-based medicines
• People who have an active autoimmune disease or a history of certain autoimmune conditions (such as autoimmune hepatitis, lung inflammation, eye inflammation, bowel inflammation, or others); some conditions such as well-controlled vitiligo or fully resolved childhood asthma may still be eligible — confirm with trial site
• People who have needed systemic medical treatment for an autoimmune disease in the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered in this category)
• People who have a build-up of fluid in the abdomen or around the lungs that is causing symptoms and requires draining
• People with significant heart problems that are not well managed, such as moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or a serious heart rhythm problem requiring treatment
• People with abnormal blood clotting results, a clear tendency to bleed, or who are currently receiving blood-thinning or clot-dissolving treatment
• People who have had a history of gastrointestinal bleeding (such as from stomach ulcers, varicose veins in the oesophagus, or inflammatory bowel conditions) or active bleeding from an unremoved tumour within the past 3 months
• People who have had a significant bleeding episode (more than 30ml in 3 months), coughing up fresh blood (more than 5ml in 4 weeks), or a blood clot, stroke, or mini-stroke within the past 12 months
• People who have an active infection during the screening period, or an unexplained fever of 38.5°C or higher before the first dose (fevers clearly caused by the tumour may be assessed differently — confirm with trial site)
• People who have had an abdominal fistula, bowel perforation, or abdominal abscess within the 4 weeks before starting the study
• People with a history of lung scarring conditions (such as pulmonary fibrosis or organising pneumonia), or who show signs of active lung inflammation on a chest scan at screening
• People with a weakened immune system due to a condition present from birth or acquired (such as HIV), or who have active hepatitis B or hepatitis C infection
• People currently taking part in another clinical trial, or who finished a previous clinical trial less than one month ago
• People who have received a live vaccine within 4 weeks before or during the study
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements
• People who, in the opinion of the treating doctor, have other serious health or personal circumstances that make participation in the study unsuitable

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