NCT05325632

Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HER-2 pulsed DC1	Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
DRUG	Trastuzumab	8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
DRUG	Pertuzumab	840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
DRUG	Paclitaxel	80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
PROCEDURE	Resection surgery	After week 18, participants will undergo standard of care resection surgery.

Timeline

• Start date: 2021-10-28
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2022-04-13
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study