Study: NCT03387553

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dendritic Cell Vaccine (DC1)
Description: 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.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Dendritic Cell Vaccine (DC1)
Description: 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.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Dendritic Cell Vaccine (DC1)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Neoadjuvant Chemotherapy
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Neoadjuvant Chemotherapy
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Neoadjuvant Chemotherapy
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Curative Surgery
Description: Planned definitive curative surgery at 26 to 28 weeks.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Curative Surgery
Description: Planned definitive curative surgery at 26 to 28 weeks.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Curative Surgery
Description: Planned definitive curative surgery at 26 to 28 weeks.