Phase 1 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 at the time of the screening visit.
• People diagnosed with breast cancer that has spread or cannot be surgically removed, where the cancer tests positive for a protein called HER2 (at any of the recognised HER2 levels: IHC 1+, 2+, or 3+), and who have already been through 2 to 3 rounds of cancer treatment.
• People with a life expectancy of at least 3 months.
• People whose general physical functioning falls within a certain range on a standard medical scale used to measure how well a person can carry out daily activities (ECOG score of 0, 1, or 2 — confirm with trial site).
• People whose bone marrow, kidneys, liver, heart, and lungs are functioning well enough, based on the treating doctor's assessment of test results.
• People whose heart electrical activity reading (ECG) shows no significant abnormalities, no specific conduction problems, and no signs of a previous heart attack (confirm with trial site).
• People who have recovered from significant side effects of previous cancer treatments or surgery, with any remaining side effects being mild to moderate, except for hair loss, nerve-related symptoms, or limb swelling, which may still be present.
• Female patients who are not pregnant, have gone through menopause, or are using a reliable method of contraception.
• Male patients who have had a sterilisation procedure or are using a reliable method of contraception.

Who may not be able to join:

• People who are planned to receive, or have received in the past month, certain types of chemotherapy given through a vein or immune checkpoint inhibitor drugs, and who currently have low white blood cell counts as a result. (Note: ongoing treatment with certain HER2-targeted medicines or antibody-drug combinations for spread breast cancer may be allowed at the treating doctor's discretion — confirm with trial site.)
• People with active brain metastases (cancer that has spread to the brain) causing symptoms that require high doses of steroid medication within the 14 days before the first dose of the trial drug.
• People who have taken part in another clinical trial involving an experimental drug, device, or intervention within the past 21 days or within a timeframe related to how long the previous drug stays in the body.
• People with serious or poorly controlled medical or mental health conditions unrelated to their cancer, which the investigator believes could affect their safety or the trial results.
• People with a previously confirmed diagnosis of coronary artery disease or moderate-to-severe heart failure.
• People whose heart pumping function, measured by an ultrasound of the heart, is below a certain level (LVEF less than 55% — confirm with trial site).
• People with uncontrolled high blood pressure.
• People with an active or suspected disease where the immune system attacks the body (autoimmune disease), except for thyroid conditions that are well managed with thyroid medication, or well-controlled insulin-dependent diabetes.
• People who need long-term use of medications that suppress the immune system (short-term low-dose use may be considered — confirm with trial site).
• People who have had a serious infection requiring antibiotics given through a vein within the 14 days before starting the trial.
• People who regularly take antiviral medications, unless those medications are for HIV, hepatitis B, or hepatitis C.
• People with a history of severe allergic reactions to any ingredient in the trial drug.
• People who have received a live or live-weakened vaccine within 30 days before the first dose of the trial treatment. (Non-live vaccines such as inactivated or recombinant vaccines are permitted.)
• People with birthmarks, tattoos, open wounds, or skin conditions on the upper arm (deltoid area) or buttocks that could make it difficult to assess injection site reactions.
• Female patients who are pregnant or currently breastfeeding.
• People with any active infection — including COVID-19 — that, in the treating doctor's opinion, could put the patient's safety at risk if they joined the trial.

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