Clinical trial · Interventional
HER-2 Protein Vaccine in Treating Women With Breast Cancer
A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer
NCT00068614CI-TRIAL-00013674completedPhase 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)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu peptide vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:
* Metastatic disease currently in complete or partial response or stable disease
* Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy
* Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:
* Stage IIB with involvement of at least 4 nodes
* Stage IIIA (T3 disease with involvement of at least 4 nodes)
* Any stage IIIB or IIIC disease
* Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
* 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
* Treatment with trastuzumab (Herceptin®) not clinically indicated
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
Hepatic
* ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
* Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)
Renal
* Creatinine no greater than 2 mg/dL
Cardiovascular
* No history of significant cardiovascular disease
* No myocardial infarction within the past 6 months
* No poorly controlled cardiac arrhythmia
* No New York Heart Association class III or IV heart disease
* LVEF at least 50% by MUGA
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
* No concurrent severe autoimmune disease
* No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 months since prior trastuzumab
* No prior anticancer vaccine therapy
* No concurrent trastuzumab
* No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)
Chemotherapy
* More than 4 weeks since prior chemotherapy
* No concurrent low-dose methotrexate or cyclophosphamide
* No concurrent cytotoxic chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent corticosteroids
* Topical or inhaled steroids are allowed
* No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent)
Radiotherapy
* More than 3 months since prior radiotherapy involving more than 25% of the bone marrow
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* No prior bilateral breast procedures
Other
* More than 4 weeks since prior immunosuppressive therapy
* More than 30 days since prior investigational agents or clinical trial participation
* No other concurrent experimental or investigational agents
* No concurrent cyclosporine
* No concurrent immunosuppressive agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.