Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05325632
PHASE2

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States