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 (May 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
Cancer type
Breast Carcinoma
Biomarker criteria
Allowed: HER2 (ERBB2) negative
Allowed: HER2 (ERBB2) negative
Allowed: HER2 (ERBB2) positive
Allowed: ESR1 negative
Allowed: ESR1 positive
Allowed: PR (PGR) negative
Allowed: PR (PGR) positive
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy — advanced disease
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)
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
Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease
Cannot have received: chemotherapy
Chemotherapy <= 3 weeks prior to registration
Cannot have received: immunotherapy
Immunotherapy <= 4 weeks prior to registration
Cannot have received: HER2-targeted therapy
HER2 directed therapy <= 3 weeks prior to registration
Cannot have received: targeted therapy (CDK4/6 inhibitors, everolimus)
Targeted therapy <= 2 weeks prior to registration (e.g., CDK4/6 inhibitors, everolimus)
Cannot have received: investigational agent
Investigational agent <= 4 weeks prior to registration
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 upper limit of normal (ULN)
ANC >= 1500/uL (<= 7 days prior to registration); Platelets (PLT >= 100,000/uL) (<= 7 days prior to registration); Total bilirubin <= institutional upper limit of normal (<= 7 days prior to registration); Aspartate aminotransferase (AST) <= 2 x upper limit of normal (ULN) (<= 7 days prior to registration); Creatinine <= 1.5 x ULN (<= 7 days prior to registration); Hemoglobin >= 9.0 g/dL (<= 7 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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