drugset / Trial / NCT02593227
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).
Timeline
- Start
- 2016-04
- Primary completion
- 2021-07-15
- Completion
- 2021-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | FRα peptide vaccine | Vaccine | 165 ug | Other |
| Subject | FRα peptide vaccine | Vaccine | 500 ug | Other |