Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer
NCT01729884CI-TRIAL-00026927terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study ended early due to slow enrollment
Summary
Brief summary (as posted)
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HER-2/neu peptide vaccine)
- description
- Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
- interventionNames
- Biological: HER-2/neu peptide vaccine
Primary outcomes (2)
- measure
- Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
- timeFrame
- Up to 4 weeks
- description
- Wilson score 90% confidence intervals will be reported.
- measure
- Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
- timeFrame
- Up to 4 weeks
- description
- Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission * Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below: * Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques * Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI) * Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy * HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis * Patients must be human leukocyte antigen (HLA)-A2 positive * Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =\< 1 * Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine * Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) \>= the lower limit of normal for the facility within 3 months of enrollment to study * Subjects of reproductive ability must agree to use contraceptives during the entire study period Exclusion Criteria: * White blood cell (WBC) \< 3000/mm\^3 * Hemoglobin (Hgb) \< 10 mg/dl * Platelets \< 100,000/mm\^3 * Serum creatinine \> 2.0 mg/dl * Serum bilirubin \> 1.5 x upper limit of normal * Any contraindication to receiving sargramostim (GM-CSF) based vaccine products * Concurrent enrollment in other treatment studies * New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina * Pregnant or breast-feeding women * History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV) * Active brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.