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

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.

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

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Haten Soliman, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-06

Primary Completion

2023-08-29

Completion

2026-02-19

FDA Drug

Yes

Countries

• United States

Study Locations