CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
HER-2 pulsed Dendritic Cell Vaccinebiological
Likely dose
Not stated in 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/NCT02063724
NCT02063724Phase 1Completed
CompareCT.gov

Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Feb 14, 2014·Updated Feb 20, 2026

In Brief

A Phase 1 clinical trial evaluating HER-2 pulsed Dendritic Cell Vaccine for Breast Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsAbramson Cancer Center at Penn Medicine

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 14, 2014
Enrollment StartOct 1, 2014
Primary CompletionSep 1, 2017
Study CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.4 years ago

Interventions

HER-2 pulsed Dendritic Cell Vaccinebiological

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.