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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.
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.
Primary Outcome
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04144023 shows while recruiting
NCT04144023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 2,286-participant average among 15 other Breast Ductal Carcinoma In Situ trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT04144023's enrollment target sits among peer trials
43 14th of 15 higher than 2 of 15 other Breast Ductal Carcinoma In Situ trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Ductal Carcinoma In Situ 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.
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