A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests * Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participants must have normal organ and marrow function as defined per protocol. * Cardiac ejection fraction within i…
Interventions
- BiologicalHER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
- DrugTrastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
- DrugPertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
- DrugPaclitaxel
80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
- ProcedureResection surgery
After week 18, participants will undergo standard of care resection surgery.
Location
- Moffitt Cancer CenterTampa, Florida