OncRef

Clinical Trial: NCT03387553

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

Status:

COMPLETED

Phase:

Early Phase 1

Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute
Information Provided By:H. Lee Moffitt Cancer Center and Research Institute
Last Update Posted:2026-09-23

Study Overview

Brief Summary

The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer.

The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.

Official Title

A Pilot Study Utilizing a HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+ Breast Cancer

Conditions

Breast Cancer, Breast Cancer Female, Breast Cancer, Male, Invasive Breast Cancer, HER2-positive Breast Cancer, HER2 Positive Breast Carcinoma, Stage II Breast Cancer, Stage III Breast Cancer

Intervention / Treatment

  • Biological: Dendritic Cell Vaccine (DC1)
  • Drug: Neoadjuvant Chemotherapy
  • Procedure: Curative Surgery

Other Study ID Numbers

  • MCC-19337

Start Date (Actual)

2018-06-06

Primary Completion Date (Actual)

2023-08-29

Study Completion Date (Actual)

2026-02-19

Enrollment (Actual)

31

Study Type

Interventional

Phase

Early Phase 1