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 are willing to take part voluntarily, have signed a consent form, and are able to follow the study requirements
• Women between 18 and 70 years old
• People who have been diagnosed with triple-negative breast cancer (a type of breast cancer that lacks three specific receptors), confirmed through tissue or cell testing
• People whose triple-negative breast cancer cannot be surgically removed, or has spread to other parts of the body, and has stopped responding to or come back after at least one standard chemotherapy treatment (such as taxanes and/or anthracyclines)
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light activity (confirm with trial site)
• People whose life expectancy is at least 12 weeks
• People whose blood counts meet minimum levels — including white blood cells, platelets, and haemoglobin — without having had a blood transfusion in the 14 days before testing
• People whose liver function test results are within acceptable ranges (or within a higher acceptable range if liver spread is present)
• People whose kidney function results are within acceptable ranges
• People whose blood clotting test results are within acceptable ranges
• People whose thyroid hormone levels are within acceptable ranges (certain cases with slightly abnormal thyroid results may still be considered — confirm with trial site)
• Women who could become pregnant must have a negative pregnancy blood test within 14 days before starting treatment, and must agree to use medically approved contraception during the study and for 3 months after the last dose

Who may not be able to join:

• People who have had surgery, chemotherapy, radiation therapy, targeted therapy, immunotherapy, or other experimental treatments in the 4 weeks before starting the trial
• People who have previously been treated with anti-VEGF or anti-VEGFR drugs, such as Bevacizumab (a drug that targets blood vessel growth in tumours)
• People who have previously received certain immune checkpoint therapies, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar treatments that affect how the immune system responds to cancer
• People who have taken immune-suppressing medications in the 14 days before starting the trial (certain low-dose steroids used for normal body function, or nasal and inhaled steroids, may be exceptions — confirm with trial site)
• People who have a history of active autoimmune diseases — conditions where the immune system attacks the body — such as autoimmune hepatitis, certain lung, eye, or bowel conditions, or thyroid disorders (some milder conditions that have been fully resolved since childhood, such as vitiligo or asthma requiring no treatment, may be exceptions — confirm with trial site)
• People who have had an organ or blood stem cell transplant from another person
• People with high blood pressure that is not well controlled by medication (systolic pressure at or above 140 mmHg or diastolic pressure at or above 90 mmHg)
• People whose urine tests show high levels of protein, and whose 24-hour urine protein measurement is above 1.0g
• People who have had significant bleeding in the 3 months before the trial, including vomiting blood, blood in stools, or bleeding of more than 30 mL; or who have coughed up fresh blood (more than 5 mL) in the 4 weeks before the trial
• People who have had a blood clot event in the 6 months before the trial, such as a stroke, mini-stroke, brain bleed, deep vein clot, or clot in the lungs
• People who require ongoing anticoagulant treatment with warfarin or heparin, or who need high-dose daily antiplatelet medicines (such as aspirin at 300 mg or more per day, or clopidogrel at 75 mg or more per day)
• People who have had a heart attack or severe chest pain in the 6 months before the trial, or whose heart pumping function is below 50%, or who have poorly controlled irregular heart rhythms, including a specific heart electrical measurement (QTcF interval) above 470 ms in women
• People who have had another cancer in the past 3 years or currently have another cancer (certain fully treated skin cancers or cervical pre-cancers may be exceptions — confirm with trial site)
• People who are known to be allergic to the study drug or any of its ingredients, or who have had a severe allergic reaction to other similar medicines (monoclonal antibodies)
• People who have an active or uncontrolled serious infection
• People known to have HIV infection
• People known to carry hepatitis B virus with active infection (confirmed by specific blood test levels)
• People known to have active hepatitis C virus infection (confirmed by specific blood test levels), or who have cirrhosis or other significant liver disease
• People who have any other medical condition, abnormal test results, or physical condition that the trial doctor believes could make the study drug unsafe for them or make it difficult to interpret the trial results
• People who the trial doctors consider unsuitable for the study for any other reason

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