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 have been diagnosed with HER2-negative metastatic breast cancer (such as triple negative breast cancer, metaplastic breast cancer, or high-grade estrogen-positive breast cancer) that is likely to carry a protein called GD2, confirmed by a lab test on a tissue sample, with stored tumour tissue available for testing
• People whose cancer can be measured on scans according to standard medical guidelines
• People who have received at least one prior treatment for their metastatic cancer and whose cancer has continued to grow, or who could not tolerate that treatment
• People aged 18 or older, of any gender
• People who are generally well enough to carry out light activity and care for themselves (assessed using a standard medical scale called ECOG, scoring 0 or 1)
• People whose blood cell counts meet minimum levels — including white blood cells, platelets, and haemoglobin (a blood transfusion to reach the required haemoglobin level in the 24 hours before dosing is permitted)
• People whose kidneys are functioning at an adequate level, based on blood or urine tests
• People whose liver is functioning at an adequate level, based on blood tests (different limits apply for people with liver spread or a condition called Gilbert's syndrome)
• Women who could become pregnant must agree to use two highly effective forms of contraception (including a physical barrier method) during the trial and for 7 months after the last dose; men must agree to use two highly effective forms of contraception and not donate sperm during the trial and for 6 months after the last dose
• People living with HIV may be eligible if their HIV is well controlled on antiviral medication for more than 4 weeks, their viral load is very low (under 400 copies/mL in the last 3 months), their immune cell count is above a certain level, and they have not had serious HIV-related infections in the past 6 months (some minor infections that have been treated may be acceptable — confirm with trial site)
• People with chronic hepatitis B may be eligible if the virus is undetectable while on treatment
• People with a history of hepatitis C may be eligible if they have been successfully treated and cured, or if they are currently being treated and the virus is undetectable at least 12 weeks after completing treatment
• People who are willing and able to read and sign a consent form
• People whose side effects from previous treatments have largely resolved to a mild level or better

Who may not be able to join:

• People who have received chemotherapy, experimental treatments, or radiation within the 3 weeks before joining the trial
• People with active, spreading cancer in the brain or the lining of the brain; people with previously treated brain metastases may be considered if scans show no growth for at least 6 months and a recent scan (within 28 days) confirms this, and they are not taking high-dose steroid medication for that condition
• People who have had another invasive cancer diagnosed within the past 3 years (certain skin cancers and some very early-stage cancers may be excepted — confirm with trial site)
• People who have had serious allergic reactions to medications that are chemically similar to those used in this trial
• People with serious uncontrolled health conditions, such as an active infection requiring ongoing antibiotic treatment, unexplained fever in the past week, unstable heart conditions, or mental health or personal circumstances that the lead doctor believes would prevent safe participation
• People with bone metastases who have started a bone-strengthening medication called denosumab or a bisphosphonate within 28 days before or after the first treatment dose (continuing a pre-existing prescription is allowed)
• People with active or suspected autoimmune diseases that significantly affect the immune system, such as inflammatory bowel disease, lupus, multiple sclerosis, or scleroderma (some milder autoimmune conditions may be acceptable — confirm with trial site)
• People taking ongoing immunosuppressive medication after an organ transplant
• People currently taking regular systemic (whole-body) steroid medication at doses higher than a low replacement dose (steroids must have been stopped more than 2 weeks before the trial starts; short-term or local steroid use may be acceptable — confirm with trial site)
• People who are pregnant or breastfeeding, or people of childbearing potential who are not using two adequate methods of contraception
• People with significant heart problems, including serious heart muscle disease, recent heart attack, severe heart failure, low heart pumping function (ejection fraction below 50%), or a stroke within the past 6 months
• People with a history of inflammation of the heart muscle (myocarditis)
• People who have received a live vaccine within 30 days before joining the trial (inactivated vaccines, including COVID-19 vaccines, are generally allowed)
• People with significant breathing difficulties, low oxygen levels at rest, or abnormal lung function test results
• People whom the lead doctor considers unsuitable for the trial for any other reason

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