A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ Age \>= 18 years
- ✓ COHORT 1 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR) /HER2 status and radiographic evidence of distant metastatic disease
- ✓ COHORTS 2 \& 3 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease
- ✓ COHORT 1 ONLY: Radiographic evidence of distant metastatic disease (using 7th edition American Joint Committee on Cancer \[AJCC\] criteria) with two discrete sites of measurable disease
- ✓ COHORTS 2 \& 3 ONLY: Radiographic evidence of distant metastatic or recurrent disease (using 8th edition AJCC criteria) with at least one site of measurable disease
- ✓ Prior therapies:
- ✓ 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
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Rochester
Source: ClinicalTrials.gov · NCT04521764 · last updated 2026-06-17