Clinical trial · Interventional
Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
NCT01479244CI-TRIAL-00026166PRESENTcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer With Low to Intermediate HER2 Expression | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leukine® (sargramostim, GM-CSF) and water for injection | Biological | — | UNRESOLVED |
| NeuVax™ vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NeuVax™
- description
- NeuVax™ in WFI solution with Leukine®
- interventionNames
- Biological: NeuVax™ vaccine
- type
- ACTIVE_COMPARATOR
- label
- Leukine®
- description
- Leukine® with WFI
- interventionNames
- Biological: Leukine® (sargramostim, GM-CSF) and water for injection
Primary outcomes (1)
- measure
- Comparison of DFS in vaccine treated patients and control patients
- timeFrame
- 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Pathological diagnosis of invasive adenocarcinoma of the breast * Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery * One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II: 1. Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II 2. BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes * Node-positive disease * Primary tumor stage T1-3 at initial diagnosis * HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH) * HLA-A2 or HLA-A3 haplotype * Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both * Completed radiation therapy * No evidence of disease * Able and willing (or have legal representative) to understand the study and provide consent Key Exclusion Criteria: * Bilateral breast malignancy or suspicious mass in opposite breast * Inflammatory breast malignancy * History of prior breast cancer, ductal carcinoma in situ * Prior trastuzumab therapy * New York Heart Association Stage 3 or 4 cardiac disease * Sensory/motor neuropathy ≥ Grade 2 * Autoimmune diseases or immune deficiency disease * Subjects on chronic steroid therapy, other immunosuppressive therapy
References
Publications (3)
- BACKGROUNDAmin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8. PMID 18392824
- BACKGROUNDMittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11. PMID 21989902
- DERIVEDMittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29. PMID 31036542