Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Summary
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.
Timeline
- Start
- 2017-03-31
- Primary completion
- 2025-02-28
- Completion
- 2026-07-31
Outcome
Missed primary endpoint
registry p = 0.4087; Hazard Ratio (HR) 1.40 (95% CI 0.63 to 3.10) NCT03012100 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | Oral |
| Subject | Multi-epitope Folate Receptor Alpha Peptide Vaccine | Vaccine | — | Other |
| Subject | sargramostim | Protein / enzyme biologic | — | Other |