The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGLead in Phase: Immunogenicity of each dose level
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
Time frame: at 4 weeks
Expansion Phase: Pathologic Complete Response Rate
Pathologic complete response rate of participants treated in the Expansion Phase. Clinical efficacy will be defined by the pathologic complete response (pCR) rate, the percentage of patients who achieve pCR based on surgical pathology assessment. Pathologic Complete Response defined as no residual invasive disease in the breast and nodes (ypT0/is N0) at definitive surgery after completion of protocol therapy. The pathologic response to treatment will be assessed by the pathologist. The "Residual Cancer Burden" (RCB) for each patient as described in the online calculator also will be evaluated per the pathologist. (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3)
Time frame: at 12 months
Expansion Phase: Radiologic tumor response rate after 6 weeks
Radiologic tumor response rate measured by MRI
Time frame: at 6 weeks
Expansion Phase: Radiologic tumor response rate at completion of therapy
Radiologic tumor response rate measured by MRI
Time frame: at 12 months
Expansion Phase: Immunogenicity
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
Time frame: at 12 months
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80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
After week 18, participants will undergo standard of care resection surgery.
Recurrence Free Survival
Recurrence free survival defined as the length of time after treatment that patient survives without any signs or symptoms of cancer.
Time frame: up to 5 years