At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of DCIS confirmed by core needle biopsy
- ✓HLA-A2 positive status
- ✓ECOG performance status 0 or 1
- ✓Normal ejection fraction on echocardiogram
- ✕Invasive breast cancer (microinvasion is allowed)
- ✕Prior breast cancer within 2 years
- ✕Prior DCIS within 2 years
- ✕Autoimmune disease or conditions compromising safety
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
VADIS Trial: Phase II Trial of Nelipeimut-S Peptide Vaccine in Women With DCIS of the Breast
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Nelipepimut-S Plus GM-CSF Vaccine, and 2 other interventions for Breast Ductal Carcinoma In Situ. Completed, enrolled 43 participants across 4 sites.
Detailed Summary
This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.
Study Details
Timeline
Interventions
Correlative studies
Given ID
Given ID
Undergo surgery