drugset / Trial / NCT03387553

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

NCT03387553

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-06-06
Primary completion
2023-08-29
Completion
2026-02-19

Drugs

EvaluationDrugModalityDoseRoute
Subject HER2-DC1 Vaccine 2e+07 cells Other
Background Carboplatin Small molecule Intravenous
Background Docetaxel Small molecule Intravenous
Background Pertuzumab Monoclonal antibody Intravenous
Background Trastuzumab Monoclonal antibody Intravenous