Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Breast Cancer
Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients
- 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)
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AE37 + GM-CSF vaccine | Biological | — | UNRESOLVED |
| GM-CSF (sargramostim) | Biological | — | UNRESOLVED |
| GP2 peptide + GM-CSF vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- HLA-A2-positive patients receive GP2 peptide + GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations.
- interventionNames
- Biological: GP2 peptide + GM-CSF vaccine
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
- interventionNames
- Biological: GM-CSF (sargramostim)
- type
- EXPERIMENTAL
- label
- Arm III
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: 1. Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria: * T2 disease * Grade 3 disease * Lymphovascular invasion * Estrogen receptor- or progesterone receptor-negative disease * HER2/neu-expressing tumor (immunohistochemistry \[IHC\] 3+ and/or amplified fluorescence in situ hybridization \[FISH\] \>2.2, or N0 (i+)) 2. HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH \>1.2) 3. Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer) 4. Clinically cancer-free (no evidence of disease) 5. Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies 6. Good performance status (as defined in Exclusion Criteria) 7. Capable of informed consent Exclusion criteria: 1. HER2/neu-negative breast cancers (IHC 0) 2. Clinical and/or radiographic evidence of residual or persistent breast cancer 3. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate 4. In poor health (Karnofsky \<60%, ECOG \>/-2) 5. Total bilirubin \>1.8, creatinine \>2, hemoglobin \<10, platelets \<50,000, WBC \<2,000) 6. Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease 7. Pregnancy (urine hCG) 8. Breast feeding 9. History of autoimmune disease 10. Involved in other experimental protocols (except with permission of the other study PI) PATIENT CHARACTERISTICS: Inclusion criteria: * Female or male * Menopausal status not specified * Immunologically intact by recall anergy testing * Negative pregnancy test Exclusion criteria: * Karnofsky 0-60% or ECOG ≥ 2 * Total bilirubin \> 1.8 g/dL * Creatinine \> 2.0 g/dL * Hemoglobin \< 10.0 g/dL * Platelet count \< 50,000/mm³ * WBC\< 2,000/mm³ * Active pulmonary disease requiring medication that includes multiple inhalers * Pregnancy * Breastfeeding * History of autoimmune disease PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate * Concurrent participation in another experimental treatment (except with permission of the other study investigator)
References
Publications (3)
- BACKGROUNDMittendorf EA, Alatrash G, Xiao H, Clifton GT, Murray JL, Peoples GE. Breast cancer vaccines: ongoing National Cancer Institute-registered clinical trials. Expert Rev Vaccines. 2011 Jun;10(6):755-74. doi: 10.1586/erv.11.59. PMID 21692698
- RESULTSears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Nov;11(11):1543-50. doi: 10.1517/14712598.2011.616889. Epub 2011 Sep 6. PMID 21895539
- DERIVEDJackson DO, Trappey FA, Clifton GT, Vreeland TJ, Peace KM, Hale DF, Litton JK, Murray JL, Perez SA, Papamichail M, Mittendorf EA, Peoples GE. Effects of HLA status and HER2 status on outcomes in breast cancer patients at risk for recurrence - Implications for vaccine trial design. Clin Immunol. 2018 Oct;195:28-35. doi: 10.1016/j.clim.2018.06.008. Epub 2018 Jul 17. PMID 30025819