OncoMatch/Clinical Trials/NCT04521764
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Is NCT04521764 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein for anatomic stage iv breast cancer ajcc v8.
Treatment: Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Disease stage
Required: Stage IV (other)
Metastatic disease required
Radiographic evidence of distant metastatic or recurrent disease (using 7th/8th edition AJCC criteria) with measurable disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy — advanced disease, ER/PR positive, HER2 negative breast cancer
Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy or combination of endocrine therapy with other agents such as CDK4/6 inhibitors
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab) — HER2 positive breast cancer
Patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for HER2 directed therapy with trastuzumab or pertuzumab
Must have received: cytotoxic chemotherapy — advanced disease, ER/PR/HER2 negative breast cancer
Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease
Cannot have received: viral or gene therapy
Any viral or gene therapy prior to registration
Lab requirements
Blood counts
ANC >= 1500/uL; Platelets >= 100,000/uL; Hemoglobin >= 9.0 g/dL
Kidney function
Creatinine <= 1.5 x ULN
Liver function
Total bilirubin <= institutional upper limit of normal; AST <= 2 x ULN
ANC >= 1500/uL; Platelets >= 100,000/uL; Total bilirubin <= institutional upper limit of normal; AST <= 2 x ULN; Creatinine <= 1.5 x ULN; Hemoglobin >= 9.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04521764 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior viral or gene therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages