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:

• Adults aged 18 or older
• People whose general health and ability to carry out daily activities meets a certain standard (a score of 0 or 1 on a scale doctors use to measure this — confirm with trial site)
• People diagnosed with high-risk, early-stage triple negative breast cancer (a type of breast cancer where the tumour tests negative for three specific markers: oestrogen receptor, progesterone receptor, and HER2)
• People whose tumour meets certain size and lymph node involvement criteria as assessed by their doctor (confirm with trial site)
• People whose treatment plan already includes chemotherapy and an immune checkpoint inhibitor (a type of cancer medicine that helps the immune system fight cancer) before surgery, as part of standard care
• People whose blood counts, liver, kidney, and clotting results fall within acceptable ranges, based on blood tests taken within 14 days before starting the study treatment
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 14 days before starting study treatment
• Women who could become pregnant must not be pregnant, not be breastfeeding, and must be willing to use effective contraception during the study and for 120 days after the last dose
• Male participants must agree to use contraception during treatment and for at least 120 days after the last dose, and must agree not to donate sperm during this time
• People who are able to give written consent and are willing and able to follow the study requirements

Who may not be able to join:

• People whose cancer has spread to other parts of the body (metastatic disease)
• People who have taken part in another clinical trial or used an experimental treatment or device within the past 4 weeks
• People with a history of significant bleeding problems or blood clotting disorders, including coughing up blood (beyond small amounts from a routine procedure), significant nosebleeds, or who are on blood-thinning medications that are not considered stable by their treating doctor
• People with high blood pressure that remains poorly controlled (repeatedly at or above 150/100 mmHg) even after taking blood pressure medication
• Women who are pregnant, planning to become pregnant, or currently breastfeeding
• People with a known allergy to any ingredient in the study medicines
• People with a history of autoimmune diseases (conditions where the immune system attacks the body)
• People with a history of another cancer, except for certain treated skin cancers, treated early-stage cancers now in full remission, cervical cancer in situ, or any cancer from which the person has been disease-free for at least three years
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with an active infection currently requiring systemic (whole-body) treatment
• People with a known history of HIV infection
• People with known active Hepatitis B or active Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People who have had unstable chest pain (angina), a heart attack, significant heart failure, unstable blood vessel disease, or other heart problems requiring hospitalisation within the past 12 months, or other heart conditions that could affect safety in the trial
• People with a certain abnormality in the heart's electrical activity (a prolonged QTc interval above 480 milliseconds on an ECG — confirm with trial site)
• People who have previously had a bone marrow transplant from a donor, or a solid organ transplant
• People with a history of certain serious digestive tract problems — including varicose veins in the oesophagus or stomach, severe ulcers, wounds that won't heal, abdominal fistulas, abscesses, or active gastrointestinal bleeding — within the past 6 months
• People who have had a serious blood clot in an artery at any time, a serious blood clot in a vein (grade 3 or above), a mini-stroke (TIA), stroke, hypertensive crisis, or hypertensive brain injury within the past 12 months
• People who have had a sudden worsening of chronic obstructive pulmonary disease (COPD) within the past 4 weeks
• People with a history of a hole (perforation) or abnormal connection (fistula) in the digestive tract, bowel blockage requiring intravenous nutrition, or major bowel surgery within the past 6 months
• People currently receiving or planning to receive other anti-cancer treatments not included in this study, such as certain types of radiotherapy, immunotherapy, hormone therapy, or specific targeted medicines
• People who have received a live vaccine within 30 days before starting the study, or who plan to receive one within 120 days after the last dose (examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, and certain nasal flu vaccines — injected seasonal flu vaccines are generally allowed)
• People who have previously received systemic treatment or radiotherapy aimed at curing the current breast cancer
• People who have already had surgery on the affected breast for the current breast cancer
• People who have previously received certain immune therapy medicines that target specific immune pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar treatments)
• People taking immune-suppressing medicines (such as prednisone above 10 mg per day, methotrexate, azathioprine, or TNF-alpha blockers), with some exceptions allowed — confirm with trial site
• People who have had major surgery within 28 days before starting the study, or within 4 weeks after the first dose, or who have not fully recovered from a recent major surgery
• People with any other condition that, in the doctor's judgement, would make participation unsafe

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