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

Major Program(s) or Research Group(s)

  • Breast and Gynecologic Cancer
  • Phase 0/I/II Cancer Prevention Clinical Trials Program

Sponsor

University of Washington

Status

Active, not recruiting

ClinicalTrials.gov ID

For more information, see ClinicalTrials.gov NCT02780401

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.

Intervention

Laboratory Biomarker Analysis, Sargramostim, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

Condition

HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Investigators

Kari Wisinski

See list of participating sites