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PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.
Details
| Lead sponsor | Galena Biopharma, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 758 |
| Start date | 2011-11 |
| Completion | 2016-09-21 |
Conditions
- Breast Cancer With Low to Intermediate HER2 Expression
Interventions
- NeuVax™ vaccine
- Leukine® (sargramostim, GM-CSF) and water for injection
Primary outcomes
- Comparison of DFS in vaccine treated patients and control patients — 36 months
The primary objective is to compare the DFS in subjects with operable early-stage, node-positive breast cancer who receive standard of care multimodality therapy plus NeuVax™ as the treatment group or standard of care multimodality therapy plus the vaccine adjuvant, Leukine® as the control group.
Countries
United States, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Poland, Romania, Russia, Ukraine, United Kingdom