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:

• People aged 18 or older.
• People who have been diagnosed with invasive breast cancer (confirmed by tissue testing) with known hormone receptor (ER/PR) and HER2 status, and whose cancer has spread to distant parts of the body or has come back.
• People whose scans show measurable areas of disease — at least two separate measurable sites for Cohort 1, or at least one measurable site for Cohorts 2 and 3.
• People with hormone receptor-positive, HER2-negative breast cancer who have already received at least one chemotherapy treatment for advanced disease and are no longer considered candidates for standard hormone-based therapies.
• People with HER2-positive breast cancer who have already received, or are no longer considered candidates for, HER2-targeted treatments such as trastuzumab or pertuzumab.
• People with triple-negative breast cancer (ER/PR/HER2 negative) who have already received at least one chemotherapy treatment for advanced disease.
• People who have at least one tumour site larger than 1 cm (or larger than 2 cm for lung tumours) that a specialist radiologist determines can be safely injected — required for Cohort 1.
• People whose recent blood test results (taken within 7 days before joining) show that blood counts, liver function, and kidney function are within acceptable ranges set by the trial.
• Women of childbearing potential who have a negative pregnancy test within 7 days before joining.
• People with a general health/activity level rated 0, 1, or 2 on a standard medical scale, meaning they are able to carry out at least some daily activities (confirm with trial site).
• People who are able to understand and sign a written consent form.
• People who are willing to return to the enrolling Mayo Clinic site for follow-up visits.
• People who are willing to provide biological samples for research purposes.
• People with a life expectancy of at least 12 weeks.
• People already taking bone-strengthening medications (such as zoledronic acid or denosumab) for bone metastases may still be eligible, provided they have previously tolerated these medications.

Who may not be able to join:

• People for whom a standard treatment is available that could cure their disease or is known to meaningfully extend life expectancy.
• People whose scans or symptoms suggest their organs may be in immediate danger due to the tumour pressing on or invading vital areas.
• People who have had an active infection within 5 days before joining.
• People who have had another cancer diagnosis within the past 5 years, except for certain non-invasive skin cancers or early-stage cervical abnormalities.
• People who have received chemotherapy within 3 weeks, immunotherapy within 4 weeks, HER2-targeted therapy within 3 weeks, certain targeted therapies (such as CDK4/6 inhibitors or everolimus) within 2 weeks, or an experimental treatment within 4 weeks before joining.
• People who have ever received any viral or gene therapy at any point before joining.
• People who have not fully recovered from side effects of previous cancer treatments.
• People with significant heart problems, including serious heart failure, known or suspected coronary artery disease, or certain heart rhythm disorders such as atrial fibrillation.
• People with brain metastases that are untreated or getting worse — though people with previously treated brain metastases may be considered if they have no symptoms and their brain scans have been stable for at least 3 consecutive months, including within 28 days of joining.
• People who regularly require blood transfusions or blood product support.
• People who have tested positive for HIV or have another form of immune deficiency.
• People who have had an organ transplant.
• People with a history of chronic hepatitis B or C infection.
• People currently receiving other chemotherapy, immunotherapy, radiation therapy, or any other experimental treatment.
• People taking any medications that the lead researcher determines could interfere with the trial.
• People who are taking oral or systemic (whole-body) corticosteroid (steroid) medications — topical creams or inhaled steroids are generally acceptable.
• People who live with, or are regularly in contact with, children under 15 months of age, or with anyone who has a known immune deficiency.
• People who have a known allergy to the measles vaccine or who have had a severe reaction to a measles vaccination in the past.
• People who received the "killed" measles vaccine given between 1963 and 1967 and did not later receive two doses of the standard live measles vaccine.

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