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MV-s-NAP for Metastatic Breast Cancer

This study is testing a modified measles virus called MV-s-NAP for patients with invasive breast cancer that has spread to other parts of the body (metastatic). Researchers want to find the safest and most effective dose of MV-s-NAP. This modified virus has an extra gene that helps it make a protein called NAP, which is involved in inflammation. The study will look at how well the treatment shrinks tumors and any side effects you might experience. To join, you must be at least 18 years old and have a confirmed diagnosis of metastatic invasive breast adenocarcinoma, with known ER/PR/HER2 status.

Study design
This study is an interventional trial with a planned enrollment of 54 participants. It aims to determine the maximum tolerated dose and safety of MV-s-NAP.
What's involved
You would undergo procedures such as CT scans, MRI scans, tumor biopsies, and provide blood and urine samples. The study will measure side effects and tumor response for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 2 years to assess tumor response and the incidence of adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04521764

A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~54 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating ProteinComputed TomographyMagnetic Resonance ImagingBiopsyBiospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over During the first cycle of treatment (each cycle = 21 days)
+4 more outcomes measured

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Invasive Breast Carcinoma
Metastatic Breast Adenocarcinoma
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7

Explore related trials

Breast CarcinomaERBB2 GenePGR Gene

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Siddhartha Yadav, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease
COHORT 1: At least one site of recurrent/metastatic disease that measures \> 1 cm in greatest dimension (\> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral administration of MV-s-NAP as determined by an interventional radiologist
COHORTS 2 \& 3 ONLY: At least 1 site of recurrent/metastatic disease measuring \> 1 cm in greatest dimension \[\> 2 cm for lung lesions\] (Note that if the lesion injected in cycle 1 is not amenable to re-injection, another lesion could be selected for injection
Absolute neutrophil count (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)
Negative pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Ability to provide informed written consent
Willingness to return to the Mayo Clinic enrolling institution for follow-up
Willingness to provide biologic samples for correlative research purposes
Life expectancy \>= 12 weeks
Concomitant administration of a bone modifying agent (e.g., zoledronic acid or denosumab) is permitted for the prevention or management of skeletal related events in patients with bone metastases and documentation of tolerability with prior exposures

Exclusion

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
Failure to fully recover from acute, reversible effects of prior systemic therapy regardless of interval since last treatment
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \[SVT\])
Untreated or progressive central nervous system (CNS) metastases
NOTE: Patients with a history of treated brain metastases (surgical resection, whole brain radiation, and/or stereotactic radiosurgery) are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including \< 28 days of study entry
Standing requirement for blood product support
Human immunodeficiency virus (HIV) positive test result or history of other immunodeficiency
History of organ transplantation
History of chronic hepatitis B or C
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
Any concurrent medications that the principal investigator determines could interfere with the trial
Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids or low dose systemic steroids for physiologic replacement (e.g., Prednisone ≤10 mg/day)
Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency
Allergy to measles vaccine or history of severe reaction to prior measles vaccination
History of receiving the measles vaccination with the "killed vaccine" between 1963-1967 without subsequent re-immunization (2 doses) with the active, live vaccination."

What this trial measures

  • Maximum tolerated doseDuring the first cycle of treatment (each cycle = 21 days)

    This is defined as the highest dose level among those under consideration where at most one of 6 patients develops a dose limiting toxicity, and two or more of the 3-6 patients treated at the next higher dose level develop a dose limiting toxicity.

  • Best tumor responseUp to 2 years

    The best tumor response in the injected and non-injected lesion will be determined using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Results will be tabulated for the entire cohort and by breast cancer subtype in terms of whether there was response in none of the lesions, only the injected lesion, or both lesions.

  • Incidence of adverse eventsUp to 2 years

    The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity, as well as the percentage of patients developing a severe (grade 3 or higher) toxicity, will be determined.

  • Measles virus viremiaUp to 2 years

    Defined as detection of any titer of virus by quantitative real time-polymerase chain reaction performed with patient peripheral blood mononuclear cells. Viremia will be examined in terms of the day and dose level it was detected, as well as the time to recovery.

  • Peripheral immune responseUp to 2 years

    Peripheral immune response specific to measles virus is defined as detection of serum IgG anti-measles antibody levels of \> 20.0 EU/mL by the Enzyme Immunoassay. Peripheral anti-neutrophil activating protein (NAP) transgene response will be represented by antibody titers determined by an antigen-mediated enzyme linked immunosorbent assay against purified helicobacter pylori NAP antigen. Systemic induction of HMGB1 will also be determined. All of these factors will be examined in terms of the day and dose level they were detected, as well as the time to recovery. For each dose level, the point at which viral replication and measles virus shedding is no longer seen will be tabulated.