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

ClinicalTrials.gov ID: NCT00854789

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Official title

Phase Ib Trial of HER2/Neu Peptide (E75) Vaccine in Node Negative Breast Cancer Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00854789
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: COL George Peoples, MD, FACS; Federal
Enrollment: 95 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

E75 + GM-CSF vaccine Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2002 (Type not available)
Primary completion: May 2012 (Actual)
Completion: Mar 2013 (Actual)
Last update posted: Mar 31, 2020

2002 – 2013

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Walter Reed Army Medical Center	Washington D.C.	District of Columbia	20307-5001	—
Windber Medical Center	Windber	Pennsylvania	15963	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00854789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 31, 2020 · Synced Nov 13, 2026