Clinical trial · Interventional
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients
Phase Ib Trial of HER2/Neu Peptide (E75) Vaccine in Breast Cancer Patients at Risk for Recurrence After Surgical and Medical Therapies
NCT00841399CI-TRIAL-00044349completedPhase 1ClinicalTrials.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)
The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the peptide vaccine 4. To evaluate time to recurrence in the vaccinated patients vs. matched controls
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E75 + GM-CSF vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- E75 + GM-CSF vaccine
- description
- The dose escalation scheme is for three patients to receive each of the doses, 100, 500, and 1,000 mcg of peptide + 250 mcg GM-CSF each month for 6 months until the maximum tolerated dose is determined. Patients who receive the vaccine are HLA-A2+ and/or HLA-A3+. Responses to the vaccine are measured via immunologic assays.
- interventionNames
- Biological: E75 + GM-CSF vaccine
- type
- NO_INTERVENTION
- label
- Control/observation
- description
- HLA-A2- and HLA-A3- patients do not receive the E37 + GM-CSF vaccine, but are instead enrolled to the control arm for observation.
Primary outcomes (1)
- measure
- The primary endpoints are the safety and optimal dosing of the vaccine to induce an in vivo peptide-specific immune response.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. HER2/neu expressing tumor 2. HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2- and/or HLA-A3- patients will be eligible to be included in the control group. 3. Immunologically intact with a good performance status 4. Identified as being high or intermediate risk for recurrence 5. Without evidence of disease 6. Completion of all standard first-line therapies (but may still be on hormonal therapy) Exclusion Criteria: 1. Tumor does not express HER2/neu 2. Not HLA-A2+ and/or HLA-A3+ 3. Anergic 4. Receiving immunosuppressive therapy 5. In poor health (Karnofsky \<60%, ECOG \>2 and Tbili \>1.5 and creatinine\>2) 6. Pregnant (beta HCG+) 7. Metastatic disease or have refused standard therapies 8. Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.
References
Publications (19)
- BACKGROUNDMittendorf EA, Storrer CE, Shriver CD, Ponniah S, Peoples GE. Investigating the combination of trastuzumab and HER2/neu peptide vaccines for the treatment of breast cancer. Ann Surg Oncol. 2006 Aug;13(8):1085-98. doi: 10.1245/ASO.2006.03.069. Epub 2006 Jul 24. PMID 16865596
- BACKGROUNDDehqanzada ZA, Storrer CE, Hueman MT, Foley RJ, Harris KA, Jama YH, Kao TC, Shriver CD, Ponniah S, Peoples GE. Correlations between serum monocyte chemotactic protein-1 levels, clinical prognostic factors, and HER-2/neu vaccine-related immunity in breast cancer patients. Clin Cancer Res. 2006 Jan 15;12(2):478-86. doi: 10.1158/1078-0432.CCR-05-1425. PMID 16428490
- BACKGROUNDWoll MM, Fisher CM, Ryan GB, Gurney JM, Storrer CE, Ioannides CG, Shriver CD, Moul JW, McLeod DG, Ponniah S, Peoples GE. Direct measurement of peptide-specific CD8+ T cells using HLA-A2:Ig dimer for monitoring the in vivo immune response to a HER2/neu vaccine in breast and prostate cancer patients. J Clin Immunol. 2004 Jul;24(4):449-61. doi: 10.1023/B:JOCI.0000029117.10791.98. PMID 15163902
- RESULTPeoples GE, Gurney JM, Hueman MT, Woll MM, Ryan GB, Storrer CE, Fisher C, Shriver CD, Ioannides CG, Ponniah S. Clinical trial results of a HER2/neu (E75) vaccine to prevent recurrence in high-risk breast cancer patients. J Clin Oncol. 2005 Oct 20;23(30):7536-45. doi: 10.1200/JCO.2005.03.047. Epub 2005 Sep 12. PMID 16157940
- RESULTMittendorf EA, Gurney JM, Storrer CE, Shriver CD, Ponniah S, Peoples GE. Vaccination with a HER2/neu peptide induces intra- and inter-antigenic epitope spreading in patients with early stage breast cancer. Surgery. 2006 Mar;139(3):407-18. doi: 10.1016/j.surg.2005.06.059. PMID 16546506
- RESULTHueman MT, Stojadinovic A, Storrer CE, Dehqanzada ZA, Gurney JM, Shriver CD, Ponniah S, Peoples GE. Analysis of naive and memory CD4 and CD8 T cell populations in breast cancer patients receiving a HER2/neu peptide (E75) and GM-CSF vaccine. Cancer Immunol Immunother. 2007 Feb;56(2):135-46. doi: 10.1007/s00262-006-0188-9. Epub 2006 Jun 17.