Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00854789 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by COL George Peoples, MD, FACS.

Completed
Registry status
Phase 1
Development phase
95
Enrollment target
2
Study locations

NCT00854789: Completed Phase 1 study of Breast Cancer, sponsored by COL George Peoples, MD, FACS.

NCT00854789 is a Phase 1 study of Breast Cancer that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 95 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00854789, a Phase 1 study of Breast Cancer, has completed, sponsored by COL George Peoples, MD, FACS.

COMPLETED
Registry status
Phase 1
Development phase
95 participants
Enrollment target
2
Study locations

Study Summary

The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response to the peptide vaccine yet limit toxicity. 3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune response to the peptide vaccine. 4. To correlate the efficiency of eliciting an in vivo cellular immune response to the peptide vaccine with the degree of HER2/neu expression in the patient's tumor.

Conditions Studied

Breast Cancer

Interventions

  • BIOLOGICAL E75 + GM-CSF vaccine

Study Locations (2)

District of Columbia

  • Walter Reed Army Medical Center - Washington D.C.

Pennsylvania

  • Windber Medical Center - Windber

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2002-12
Est. Completion 2013-03
Phase Phase 1

Sponsor

COL George Peoples, MD, FACS

4 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00854789

The ClinicalTrials.gov registry entry for NCT00854789 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is COL George Peoples, MD, FACS, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which E75 + GM-CSF vaccine is the first listed.

NCT00854789 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00854789 about?

NCT00854789 is a clinical study titled "Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer". The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response ...

What is the current status of trial NCT00854789?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2002-12. Estimated completion is 2013-03.

What conditions does trial NCT00854789 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00854789?

The interventions under investigation include: E75 + GM-CSF vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00854789?

This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00854789 being conducted?

This trial has 2 study locations across District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

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.

Explore more on PlainTrial

Breast Cancer

All registered trials for this condition

District of Columbia

All trials with a study site in District of Columbia

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Related

Compare this shortlist side-by-side

Read our methodology - how this data is sourced, computed, and verified.
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.