drugset / Trial / NCT02018458
Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy. The secondary objectives of this trial are to determine pathologic complete response rates; disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2- BC patients with patient-specific tumor antigens.
Timeline
- Start
- 2014-05
- Primary completion
- 2019-09-18
- Completion
- 2019-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DC vaccine | Vaccine | — | Intrathecal |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Paclitaxel | Small molecule | — | — |