31
Participants
Start Date
June 6, 2018
Primary Completion Date
August 29, 2026
Study Completion Date
August 29, 2026
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."
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.
Curative Surgery
Planned definitive curative surgery at 26 to 28 weeks.
H. Lee Moffitt Cancer Center and Research Institute, Tampa
United States Department of Defense
FED
H. Lee Moffitt Cancer Center and Research Institute
OTHER