Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer
MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas
NCT00640861CI-TRIAL-00035561completedEarly Phase 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 made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer. PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CpG oligodeoxynucleotide | Biological | — | UNRESOLVED |
| HER-2/neu peptide vaccine | Biological | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| MUC-1 peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Percentage of CD4+ T cells, CD8+ T cells, B cells, monocytes, and dendritic cells in a patient's peripheral blood sample as estimated by flow cytometry with a panel of monoclonal antibodies
- measure
- Frequency of peptide-specific IFN-gamma producing T cells and peptide-specific IL-5 producing T cells estimated by ELISPOT after in vitro stimulation with peptide-sensitized stimulator cells for MUC1 and HER-2 peptides
- measure
- Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria
Secondary outcomes (2)
- measure
- Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer
- measure
- Overall survival, defined as the time from registration to death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Clinical stage II or III disease
* No radiographic evidence of disease at the time of enrollment
* Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy
* Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease
* Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:
* HER2 over-expression or amplification
* Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)
* .
* MUC1-positive breast cancer
* HLA-A2 positive
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 75,000/μL
* ANC ≥ 1,500/uL
* Creatinine ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* No uncontrolled infection
* No known HIV infection
* No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Fully recovered from acute, reversible effects of any prior breast cancer therapy
* No more than 3 years since prior surgery for primary breast cancer
* Concurrent anti-estrogen therapy is allowed
* No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
* No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intentReferences
Publications (0)
Data not yet available
No reference posted for this study.