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NCT04144023 · ClinicalTrials.gov registry record · Phase 1

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

A Phase 1 study of Breast Ductal Carcinoma In Situ, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 1
Development phase
43
Enrollment target
2
Study locations

NCT04144023: Recruiting Phase 1 study of Breast Ductal Carcinoma In Situ, sponsored by Mayo Clinic.

NCT04144023 is a Phase 1 study of Breast Ductal Carcinoma In Situ that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 43 participants, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04144023, a Phase 1 study of Breast Ductal Carcinoma In Situ, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 1
Development phase
43 participants
Enrollment target
2
Study locations

Study Summary

This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Echocardiography Test
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Granulocyte-Macrophage Colony-Stimulating Factor
  • BIOLOGICAL Multi-epitope HER2 Peptide Vaccine H2NVAC

Study Locations (2)

Florida

  • Mayo Clinic in Florida - Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2019-06-27
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT04144023

The ClinicalTrials.gov registry entry for NCT04144023 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (98% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Ductal Carcinoma In Situ appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04144023 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04144023 about?

NCT04144023 is a clinical study titled "A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ". This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting again...

What is the current status of trial NCT04144023?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-06-27. Estimated completion is 2027-12-31.

What conditions does trial NCT04144023 study?

This clinical trial studies the following conditions: Breast Ductal Carcinoma In Situ.

What interventions are being tested in trial NCT04144023?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Echocardiography Test (PROCEDURE), Therapeutic Conventional Surgery (PROCEDURE), Granulocyte-Macrophage Colony-Stimulating Factor (BIOLOGICAL), Multi-epitope HER2 Peptide Vaccine H2NVAC (BIOLOGICAL).

Who is sponsoring clinical trial NCT04144023?

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

Where is trial NCT04144023 being conducted?

This trial has 2 study locations across Florida, 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.