Actively Recruiting
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Led by Mayo Clinic · Updated on 2026-01-08
54
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For Cohort 1: Confirmed invasive breast adenocarcinoma with known ER/PR/HER2 status and radiographic evidence of distant metastatic disease
- For Cohorts 2 and 3: Confirmed invasive breast adenocarcinoma with known ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease
- For Cohort 1: Two measurable sites of metastatic disease with at least one site larger than 1 cm (or larger than 2 cm for lung lesions) suitable for safe intratumoral injection
- For Cohorts 2 and 3: At least one measurable site of recurrent or metastatic disease larger than 1 cm (or larger than 2 cm for lung lesions) suitable for injection
- Patients with ER/PR positive, HER2 negative breast cancer must have progressed after at least one prior cytotoxic regimen and are no longer candidates for standard endocrine therapies
- Patients with HER2 positive breast cancer must have received or no longer be candidates for HER2 targeted therapies like trastuzumab or pertuzumab
- Patients with triple-negative breast cancer must have progressed after at least one prior cytotoxic regimen
- Absolute neutrophil count at least 1500/uL within 7 days before registration
- Platelet count at least 100,000/uL within 7 days before registration
- Total bilirubin within normal limits within 7 days before registration
- AST no more than twice the upper limit of normal within 7 days before registration
- Creatinine no more than 1.5 times upper limit of normal within 7 days before registration
- Hemoglobin at least 9.0 g/dL within 7 days before registration
- Negative pregnancy test within 7 days before registration for women who can become pregnant
- ECOG performance status of 0, 1, or 2
- Ability to provide informed consent
- Willingness to return for follow-up visits at Mayo Clinic
- Willingness to provide biological samples for research
- Life expectancy of at least 12 weeks
- Use of bone modifying agents is permitted with prior tolerability documented
You will not qualify if you...
- Presence of known curative or life-extending standard therapies for the patient's disease
- Clinical or imaging signs of impending organ failure due to tumor invasion or compression
- Active infection within 5 days before registration
- History of other cancers within the past 5 years except non-melanoma skin cancer or cervical carcinoma in situ
- Receipt of chemotherapy within 3 weeks before registration
- Receipt of immunotherapy within 4 weeks before registration
- Receipt of HER2 targeted therapy within 3 weeks before registration
- Receipt of targeted therapies (e.g., CDK4/6 inhibitors, everolimus) within 2 weeks before registration
- Receipt of investigational agents or viral/gene therapy within 4 weeks before registration
- Incomplete recovery from prior systemic therapy side effects
- Significant heart disease or arrhythmias
- Untreated or progressing brain metastases; patients with treated stable brain metastases may be eligible
- Need for blood product support
- HIV positive or history of other immune deficiencies
- History of organ transplant
- Chronic hepatitis B or C infection
- Concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapies for non-approved indications
- Use of medications deemed interfering by the study doctor
- Use of systemic corticosteroids except topical or inhaled forms
- Exposure to infants under 15 months old or household contacts with immune deficiencies
- Allergy or severe reaction to measles vaccine
- History of receiving only killed measles vaccine between 1963-1967 without subsequent live vaccine doses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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