The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines. There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence. This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ultrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
HER2 DC1 Vaccine Regimen
Investigators will assess the feasibility of participants receiving the six-booster regimen if 11/15 randomized to Arm D complete all 6 booster injections.
Time frame: Up to 16 months
HER2 Immunity with 3 Booster Regimen at 18 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at 18 months from month 1 injection. treatment among women with breast cancer previously treated with HER2 vaccines. Two regimens consist of 3 versus 6 booster HER2 vaccine injections administered every 3 months
Time frame: At 18 months after first dose
HER2 Immunity with 6 Booster Regimen at 18 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at 18 months from month 1 injection. treatment among women with breast cancer previously treated with HER2 vaccines. Two regimens consist of 3 versus 6 booster HER2 vaccine injections administered every 3 months
Time frame: At 18 months after first dose
HER2 Immunity with 3 Booster Regimen at 10 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at month 10 from first vaccine treatment
Time frame: At 10 months after first dose
HER2 Immunity with 6 Booster Regimen at 10 months
To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at month 10 from first vaccine treatment
Time frame: At 10 months after first dose
Rate of Treatment Emergent Adverse Events of 3 Dose Regimen
Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 5 years
Rate of Treatment Emergent Adverse Events of 6 Dose Regimen
Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 5 years
Overall Survival
OS will be measured using the Kaplan-Meier method
Time frame: Up to 5 Years
Disease Free Survival
DFS will be measured using the Kaplan-Meier method
Time frame: Up to 5 Years
Progression Free Survival
PFS will be measured using the Kaplan-Meier method
Time frame: Up to 5 Years
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