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Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2021-10-28
Completion Date
2027-09
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
HER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
Trastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
Pertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Paclitaxel
80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
Resection surgery
After week 18, participants will undergo standard of care resection surgery.
Locations (1)
Moffitt Cancer Center
Tampa, Florida, United States