A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer (NCT04521764)
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \[DNA\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (24 items) and avoid the listed exclusions (26 items).
Location: Mayo Clinic in Rochester — Rochester, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Clinical or radiographic suspicion of impending visceral crisis due to invasion or compression by tumor
- Active infection =\< 5 days prior to registration
- History of other malignancy =\< 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix
- Any of the following prior therapies:
- Chemotherapy =\< 3 weeks prior to registration
- Immunotherapy =\< 4 weeks prior to registration
- HER2 directed therapy =\< 3 weeks prior to registration
- Targeted therapy =\< 2 weeks prior to registration (e.g., CDK4/6 inhibitors, everolimus)
- Investigational agent =\< 4 weeks prior to registration
- Any viral or gene therapy prior to registration
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic in Rochester — Rochester, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.