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NCT03384914 · ClinicalTrials.gov registry record · Phase 2

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

A Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 2
Development phase
119
Enrollment target
7
Study locations

NCT03384914 is a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 119 participants, below the 237-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (50% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT03384914, a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
119 participants
Enrollment target
7
Study locations

Study Summary

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Conditions Studied

HER2-positive Breast Cancer Breast Cancer Female Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Stage I HER2-Positive Breast Carcinoma Residual Disease Breast Cancer, Male

Interventions

  • BIOLOGICAL DC1 Vaccine
  • BIOLOGICAL WOKVAC Vaccine

Study Locations (7)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Georgia

  • Emory - Winship Cancer Institute - Atlanta

Indiana

  • Indiana University - Melvin and Bren Simon Cancer Center - Indianapolis

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo

Ohio

  • Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute - Columbus

Washington

  • University of Washington, Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2018-02-19
Est. Completion 2027-12
Phase Phase 2

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03384914

The ClinicalTrials.gov registry entry for NCT03384914 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 237-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (50% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which DC1 Vaccine is the first listed.

NCT03384914 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Florida, Georgia, Indiana.

Frequently Asked Questions

What is clinical trial NCT03384914 about?

NCT03384914 is a clinical study titled "Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer". The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will ...

What is the current status of trial NCT03384914?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2018-02-19. Estimated completion is 2027-12.

What conditions does trial NCT03384914 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I.

What interventions are being tested in trial NCT03384914?

The interventions under investigation include: DC1 Vaccine (BIOLOGICAL), WOKVAC Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03384914?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03384914 being conducted?

This trial has 7 study locations across Florida, Georgia, Indiana, New Jersey, New York. 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

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, or report a data error.