Clinical trial · Interventional
Dendritic Cell Based Therapy for Breast Cancer Patients
Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patients enrolled
Summary
Brief summary (as posted)
The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aromatase inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| DC vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aromatase inhibitor and DC vaccination
- description
- the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2
- interventionNames
- Biological: DC vaccine
- type
- ACTIVE_COMPARATOR
- label
- Aromatase inhibitor
- description
- the HLA-A2 negative patients will receive AI only
- interventionNames
- Biological: DC vaccine
- Drug: aromatase inhibitor
Primary outcomes (1)
- measure
- To determine time to progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy. * Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age \>18, PS ≤ 1 and acceptable CBC and blood chemistry results Exclusion Criteria: * Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin) * Patients with metastatic disease in the central nervous system * Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure * Patients with acute or chronic infection including HIV, hepatitis og TB * Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial * Patients who received corticosteroids or other immunosuppressive agents * Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis * Severe hypercalcemia
References
Publications (2)
- BACKGROUNDSvane IM, Pedersen AE, Johansen JS, Johnsen HE, Nielsen D, Kamby C, Ottesen S, Balslev E, Gaarsdal E, Nikolajsen K, Claesson MH. Vaccination with p53 peptide-pulsed dendritic cells is associated with disease stabilization in patients with p53 expressing advanced breast cancer; monitoring of serum YKL-40 and IL-6 as response biomarkers. Cancer Immunol Immunother. 2007 Sep;56(9):1485-99. doi: 10.1007/s00262-007-0293-4. Epub 2007 Feb 7. PMID 17285289
- BACKGROUNDSvane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25. PMID 14985857