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ACTIVE NOT RECRUITING
NCT03387553
EARLY_PHASE1

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2018-06-06

Completion Date

2026-07-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Dendritic Cell Vaccine (DC1)

Study Vaccine: Lead In Phase - Weekly as outlined in each treatment Arm. Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase. Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery. Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.

DRUG

Neoadjuvant Chemotherapy

Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.

PROCEDURE

Curative Surgery

Planned definitive curative surgery at 26 to 28 weeks.

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States