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:

• You are 18 years old or older at the time of signing the consent form
• You are able to read and sign a consent form agreeing to take part in the study
• You have been diagnosed with HER2-positive breast cancer, confirmed by a lab test on a tissue sample (any hormone receptor status is allowed)
• You have high-risk breast cancer, meaning one of the following applies: cancer was still found in breast or lymph node tissue after chemotherapy before surgery; you had inflammatory breast cancer when first diagnosed; you were diagnosed with stage III breast cancer; or your cancer came back locally and you have already received treatment for it
• You have received at least six months of HER2-targeted treatment (such as trastuzumab, with or without other HER2-targeted drugs) either before or after surgery
• Your last dose of HER2-targeted treatment was no more than 6 months before joining the study
• Your last dose of chemotherapy or radiation was at least 30 days before joining the study, and any side effects from those treatments have mostly resolved
• You are generally well enough to carry out daily activities (your doctor will assess this using a standard scale)
• Your liver, kidneys, and blood cell counts are within acceptable ranges based on blood tests
• Your heart is functioning well enough, confirmed by a heart scan done within the last 90 days
• If you could become pregnant, you must have a negative pregnancy test within 14 days of joining the study
• If you could become pregnant or can father a child, you must agree to use an effective form of contraception during the study and for 6 months after your last treatment

Who may not be able to join:

• Your cancer has spread to distant parts of the body (such as other organs)
• You currently have another active cancer (though a previous cancer that was treated and has not returned would not automatically exclude you)
• You are currently receiving, or plan to receive, a type of medication called a CDK4/6 inhibitor as part of your treatment
• You test positive for an immediate allergic reaction to specific components used in this trial's vaccine (confirm with trial site)
• You need or are likely to need steroids or other medicines that suppress the immune system
• You have an active autoimmune disease such as rheumatoid arthritis, lupus, scleroderma, or certain muscle or blood vessel conditions (though your doctor may still consider enrolling you in some circumstances)
• You have had a severe allergic reaction (anaphylaxis) to any vaccine in the past
• You currently have an active infection being treated with antibiotics, or you have not been off antibiotics for at least 3 weeks
• You have an active or confirmed HIV, hepatitis B, or hepatitis C infection (having immunity from a vaccine does not exclude you)
• You have a serious uncontrolled illness, such as heart failure, unstable chest pain, or an irregular heartbeat that is not under control
• You have serious, uncontrolled heart or lung problems (your doctor may still consider enrolling you if your condition has been stable for at least 6 months)
• You have had your spleen removed
• You are currently pregnant or breastfeeding

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