At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive breast cancer, stage III (locally advanced): primary tumor ≥4 cm AND/OR palpable axillary nodes >1 cm
- ✓p53-overexpressing tumor confirmed by immunohistochemistry
- ✓Delayed-type hypersensitivity response to at least 1 of 3 standard antigens (intact cellular immunity)
- ✓Planned neoadjuvant chemotherapy
- ✕Prior or concurrent autoimmune disorder
- ✕Prior chemotherapy
- ✕Pregnant or nursing
- ✕Concurrent participation in another therapeutic clinical trial
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
1) Adenovirus p53 Infected DC Vaccine For Breast Cancer, 2) Translation of Biotechnology Into the Clinic
In Brief
A Phase 2 clinical trial evaluating autologous dendritic cell-adenovirus p53 vaccine for Breast Cancer. Completed, enrolled 24 participants across 1 site.
Detailed Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
Study Details
Timeline
Interventions
Given subcutaneously on one of two schedules