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

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

June 6, 2018

Primary Completion Date

August 29, 2026

Study Completion Date

August 29, 2026

Conditions
Breast CancerBreast Cancer FemaleBreast Cancer, MaleInvasive Breast CancerHER2-positive Breast CancerHER2 Positive Breast CarcinomaStage II Breast CancerStage 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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER