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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 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.

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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.

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

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT04521764

The ClinicalTrials.gov registry entry for NCT04521764 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (67% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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