Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A diagnosis of HER2-negative breast cancer. * Diagnosis of HR negative or HR low positive tumor. * Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer. * Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician. * Age ≥18 years. * ECOG performance status 0 or 1. * Patients must have normal organ and marrow function, as defined below, within 14 days of registration: * \*Absolute neutrophil count (ANC) ≥ 1500/μL *…
Interventions
- BiologicalHER2 - primed Dendritic cells
Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million
- BiologicalHER3 - primed Dendritic cells
Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million
Location
- Moffitt Cancer CenterTampa, Florida