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NCT04521764 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT04521764: Recruiting Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, sponsored by Mayo Clinic.

NCT04521764 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 54 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04521764, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 1
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2020-09-23
Est. Completion 2027-08-15
Phase Phase 1
Mayo Clinic

2,844 total trials

What NCT04521764 shows while recruiting

NCT04521764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (67% lower).

The record links to 5 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04521764 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT04521764 about?

NCT04521764 is a clinical study titled "A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer". 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-...

What is the current status of trial NCT04521764?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-09-23. Estimated completion is 2027-08-15.

What conditions does trial NCT04521764 study?

This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Metastatic Breast Adenocarcinoma.

What interventions are being tested in trial NCT04521764?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein (BIOLOGICAL).

Who is sponsoring clinical trial NCT04521764?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04521764 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Anatomic Stage IV Breast Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04521764's enrollment target sits among peer trials

54 22nd of 59 higher than 38 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04521764

Source: ClinicalTrials.gov NCT04521764, the US trial registry maintained by the National Library of Medicine. NCT04521764 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.