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

Phase 2 Recruiting 53 enrolled H. Lee Moffitt Cancer Center and Research Institute ImmunoRestoration · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2021-10-28
Primary completion: 2027-02
Completion: 2027-09

Publications

Han HS, Aldrich AL, Garg SK, Weinfurtner RJ, Nguyen JV, Mo Q, Whiting J, Childress J, Soliman H, Costa R, Armaghani A, Soyano A, Kiluk J, Hoover S, Lee MC, Khakpour N, Shenoi N, Jameel Z, Koski GK, Czerniecki BJ. Alteration of the Tumor Microenvironment With Intratumoral Dendritic Cells Before Chemotherapy in ERBB2 Breast Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Feb 1;11(2):119-127. doi: 10.1001/jamaoncol.2024.5371.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Influenza Virus Vaccine	Vaccine	50 cells	Intrathecal
Subject	Influenza Virus Vaccine	Vaccine	100 cells	Intrathecal
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications