Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

Summary

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

Timeline

Start

2016-09-02

Primary completion

2020-10-08

Completion

2022-10-08

Publications

• Results Disis ML, Gad E, Herendeen DR, Lai VP, Park KH, Cecil DL, O'Meara MM, Treuting PM, Lubet RA. A multiantigen vaccine targeting neu, IGFBP-2, and IGF-IR prevents tumor progression in mice with preinvasive breast disease. Cancer Prev Res (Phila). 2013 Dec;6(12):1273-82. doi: 10.1158/1940-6207.CAPR-13-0182. Epub 2013 Oct 23.
• Stanton SE, Cecil DL, Bailey HH, Liu Y, Gwin WR, Colveler AL, Liao JB, Wisinski KB, Barroilhet L, Kim K, Havighurst TC, DeShong K, Twaroski K, Childs JS, Dimond E, Wojtowicz M, Heckman-Stoddard BM, Disis ML. Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. J Immunother Cancer. 2026 May 4;14(5):e014314. doi: 10.1136/jitc-2025-014314.

Drugs

Indications