Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
NCT00304096CI-TRIAL-00009960completedPhase 1Results postedClinicalTrials.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. Giving booster vaccinations may make a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV 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 |
|---|---|---|---|
| synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum 1: Receiving Hormone Therapy
- description
- Patients treated with 9 peptide vaccine who received hormone therapy
- interventionNames
- Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
- type
- EXPERIMENTAL
- label
- Stratum 2: Not receiving hormone therapy
- description
- Patients receiving 9 peptide vaccine who did not receive hormone therapy
- interventionNames
- Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
Primary outcomes (1)
- measure
- The Number of Participants Who Experienced Dose-limiting Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the breast * Stage III or IV disease * Primary or recurrent disease * Invasive lobular carcinoma allowed * HLA-A1, -A2, -A3, or -A31 positive * Underwent and recovered from prior primary therapy * Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months * Must have at least one undissected axillary and/or inguinal lymph node basin * No history of brain metastases * Hormone receptor status * Estrogen receptor-positive or -negative tumor PATIENT CHARACTERISTICS: * ECOG performance status of 0 or 1 * Body weight \> 110 lbs (without clothes) * Male or female * Menopausal status not specified * Absolute neutrophil count \> 1000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Hemoglobin A1c \< 7% * AST and ALT ≤ 2.5 x upper limit of normal (ULN) * Bilirubin ≤ 2.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN * Creatinine ≤ 1.5 x ULN * HIV negative * Hepatitis C negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known or suspected allergies to any component of the vaccine * No active infection requiring antibiotics * No New York Heart Association class III or IV heart disease * No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following: * Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Mild arthritis requiring nonsteroidal antiinflammatory drugs * No medical contraindication or potential problem that would preclude study participation PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior surgery * More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy * More than 4 weeks since prior and no concurrent allergy desensitization injections * More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids * No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide) * Prior or concurrent topical corticosteroids allowed * More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim) * More than 4 weeks since prior and no concurrent other investigational medication * More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents * Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed * No prior vaccination with any synthetic peptides in this protocol * Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered ≥ 2 weeks prior to or ≥ 2 weeks after study vaccine * Short term therapy for acute conditions not related to breast cancer allowed * No concurrent illegal drugs
References
Publications (0)
Data not yet available
No reference posted for this study.