Clinical trial · Interventional
Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
Development of HER-2/Neu (HER2) ICD Memory Immunity After Vaccination With a Plasmid Encoding HER2 ICD in Patients With Advanced Stage HER2 Overexpressing Breast and Ovarian Cancers
- 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: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2. PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| HER-2/neu intracellular domain protein | Biological | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| Sterile water placement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
- timeFrame
- 6 months after active immunization
Secondary outcomes (2)
- measure
- Characterization of memory T-cell population by intracellular cytokine staining
- timeFrame
- 3, 6, and 12 months after active immunization
- measure
- Quantitate memory precursor frequency by intracellular cytokine staining
- timeFrame
- 3, 6, and 12 months after active immunization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage III/IV breast cancer * Completed chemotherapy * Receiving trastuzumab (Herceptin®) monotherapy * Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female (male patients are not excluded) * Menopausal status not specified * Zubrod performance status 0 * Unable to bear children (female patients) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No cytoreductive chemotherapy within the past 30 days * No cytotoxic treatment and/or systemic corticosteroids within the past month * Concurrent local radiotherapy or hormonal therapy allowed
References
Publications (0)
Data not yet available