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NCT05455658 · ClinicalTrials.gov registry record · Phase 2

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by University of Washington.

Active
Registry status
Phase 2
Development phase
33
Enrollment target
3
Study locations

NCT05455658 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 33 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05455658, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by University of Washington.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
33 participants
Enrollment target
3
Study locations

Study Summary

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Interventions

  • BIOLOGICAL CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • BIOLOGICAL Sargramostim

Study Locations (3)

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Wisconsin

  • University of Wisconsin Carbone Cancer Center - Madison

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2022-11-17
Est. Completion 2028-07-16
Phase Phase 2

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT05455658

The ClinicalTrials.gov registry entry for NCT05455658 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is the first listed.

NCT05455658 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Maryland, Washington, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT05455658 about?

NCT05455658 is a clinical study titled "STEMVAC in Patients With Early Stage Triple Negative Breast Cancer". This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC...

What is the current status of trial NCT05455658?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2022-11-17. Estimated completion is 2028-07-16.

What conditions does trial NCT05455658 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8.

What interventions are being tested in trial NCT05455658?

The interventions under investigation include: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (BIOLOGICAL), Sargramostim (BIOLOGICAL).

Who is sponsoring clinical trial NCT05455658?

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

Where is trial NCT05455658 being conducted?

This trial has 3 study locations across Maryland, Washington, Wisconsin. 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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