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NCT02780401 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

A Phase 1 study, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT02780401: Completed Phase 1 study, sponsored by University of Washington.

NCT02780401 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02780401, a Phase 1 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

Primary Outcome

Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Sargramostim
  • BIOLOGICAL pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-09-02
Est. Completion 2022-10-08
Phase Phase 1
University of Washington

1,048 total trials

What the finished NCT02780401 record still lists

NCT02780401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02780401 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02780401 about?

NCT02780401 is a clinical study titled "Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission". This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made fr...

What is the current status of trial NCT02780401?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-09-02. Estimated completion is 2022-10-08.

What interventions are being tested in trial NCT02780401?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02780401?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02780401's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02780401, the US trial registry maintained by the National Library of Medicine. NCT02780401 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.