Vaccination of High Risk Breast Cancer Patients

Phase 1/2 Completed 58 enrolled University of Arkansas

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.

Timeline

Start: 2015-01-14
Primary completion: 2023-01-03
Completion: 2023-01-03

Publications

Hernandez Puente CV, Hsu PC, Rogers LJ, Jousheghany F, Siegel E, Kadlubar SA, Beck JT, Makhoul I, Hutchins LF, Kieber-Emmons T, Monzavi-Karbassi B. Association of DNA-Methylation Profiles With Immune Responses Elicited in Breast Cancer Patients Immunized With a Carbohydrate-Mimicking Peptide: A Pilot Study. Front Oncol. 2020 Jun 5;10:879. doi: 10.3389/fonc.2020.00879. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	P10s-PADRE	Peptide	—	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	—
Background	Docetaxel	Small molecule	75 mg/m2	—
Background	Doxorubicin	Other / unclassified	60 mg/m2	—
Background	incomplete Freund's adjuvant	Other / unclassified	—	—

Vaccination of High Risk Breast Cancer Patients

Summary

Timeline

Publications

Drugs

Indications