At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 100 enrolled

Drug / intervention

E75 + GM-CSF vaccinebiological

Likely dose

E75 + GM-CSF vaccine 1,000 mcgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00841399

NCT00841399Phase 1Completed

Compare CT.gov

Phase Ib Trial of HER2/Neu Peptide (E75) Vaccine in Breast Cancer Patients at Risk for Recurrence After Surgical and Medical Therapies

COL George Peoples, MD, FACS·interventional·Posted Feb 11, 2009·Updated Mar 31, 2020

In Brief

A Phase 1 clinical trial evaluating E75 + GM-CSF vaccine for Breast Cancer. Completed, enrolled 100 participants across 2 sites.

Detailed Summary

The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the peptide vaccine 4. To evaluate time to recurrence in the vaccinated patients vs. matched controls

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesUnited States

CollaboratorsUniformed Services University of the Health Sciences

Timeline

Phase 1CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2001

First PostedFeb 2009

Primary CompletionSep 2012

Study CompletionMar 2013

TodayJul 2026

First PostedFeb 11, 2009

Enrollment StartJul 1, 2001

Primary CompletionSep 1, 2012

Study CompletionMar 1, 2013

TodayJul 2, 2026

Enrollment to primary: 11.2 yearsPosted 17.4 years ago

Interventions

E75 + GM-CSF vaccinebiological

Dose escalation scheme involving three patients each receiving injection of 100, 500, or 1,000 mcg E75 + GM-CSF monthly for 6 months. HLA-A2 and HLA-A3 status determined. HLA-A2+ and HLA-A3+ patients receive the vaccine; HLA-A2- and HLA-A3- enrolled to the control arm.