HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy (Neoadjuvant)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy|
- Participation Compliance [ Time Frame: Up to 18 months ]Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (6 weekly vaccinations). Data collection will include rate of successful completion and occurrence rate for each reason stated for non-completion.
- Occurrence of Treatment Related Adverse Events [ Time Frame: Up to 18 months ]Number of participants with treatment related adverse events, per event category.
- Immunogenicity [ Time Frame: Up to 5 years follow-up ]Immunogenicity will be evaluated by descriptive statistics, plots of pre- and post-treatment values and fold changes. Immune response rate and 95% exact confidence interval will be calculated.
- Anti-HER2 Immunity [ Time Frame: Up to 5 years follow-up ]Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.
|Actual Study Start Date:||April 8, 2014|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.
Biological: HER-2 pulsed Dendritic Cell Vaccine
Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02061423
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Brian Czerniecki, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|