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

NCT05325632 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-03-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ImmunoRestoration

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Hyo (Heather) Han, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2027-02-28
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05325632 on ClinicalTrials.gov