Clinical trial · Interventional
Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
Investigation of the Clinical and Laboratory Efficacy of Autogemotherapy Based on Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
- 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)
The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with breast cancer. This technology is intended for complex treatment of patients with breast cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of breast cancer among women, a decrease in the average age at onset of the disease and a young age, and the chemoresistantness of locally advanced forms of 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 |
|---|---|---|---|
| Immunotherapy based on dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotherapy based on dendritic cells
- description
- Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection
- interventionNames
- Biological: Immunotherapy based on dendritic cells
Primary outcomes (1)
- measure
- Сytotoxicity
- timeFrame
- 6 months
- description
- A study of the cytotoxic activity of peripheral blood mononuclear cells against tumor cells of the MCF-7 line. The result will be presented as the level of cytotoxicity (%) against the cells of the tumor line. The determination of cytotoxicity is carried out using a lactate dehydrogenase test (Promega). The level of the enzyme is proportional to the level of cytotoxicity.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. For the first time established morphologically confirmed diagnosis of breast cancer 2. patients with II A, II B, IIIA, III B stages of breast cancer; 3. Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases; 4. Patients with HER-2 / neu 3 + positive and patients with triple negative breast cancer of the I-II stage (biologically unfavorable forms of breast cancer more prone to recurrence and metastasis). 5. Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition, 6. The patient's desire. Exclusion Criteria: 1. Pregnancy at any time, 2. Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status, 3. Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified, 4. Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components, 5. Refusal of the patient to participate in the study in oral or written form. 6. Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).
References
Publications (0)
Data not yet available