Immunogenicity and Safety of DCs in Breast Cancer (TEBICA)
|ClinicalTrials.gov Identifier: NCT03450044|
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : February 5, 2020
This study aims to evaluate for the first time in Colombia the immunogenicity and safety of autologous DCs as enhancers of the immune response in patients with ductal breast cancer who, prior to surgical resection of the tumor, will receive neo-adjuvant chemotherapy with Doxorubicin and Cyclophosphamide. concomitantly with the transfer of autologous DCs. This clinical trial is based on the concept proposed in countries like France more than a decade ago, that chemotherapy or radiotherapy cause the tumor cells to release certain signals that favor the activation of the immune system against cancer. Therefore, the combined use of chemotherapy with vaccination with dendritic cells would provide the immune system with greater antitumor response capacity, taking advantage of the release of said signals to initiate a series of processes that would be reflected in the activation of T lymphocytes capable of destroying the remaining cells of the tumor. To determine the specificity of the response evoked by the adoptive transfer of autologous DCs, in each patient the degree of recognition of the tumor by the immune system before and after said procedure will be evaluated. These results will be compared with those of patients who participated in a control group.
Hypothesis Adoptive transfer of autologous DCs generated in vitro, in patients with stage IIA-IV breast cancer who receive neoadjuvant therapy with Doxorubicin and Cyclophosphamide, is a safe procedure that stimulates anti-tumor immune responses in treated patients.
To evaluate the safety and immunogenicity of the use of DCs when used in patients with stage IIA-IV breast cancer in association with neo-adjuvant chemotherapy with Doxorubicin/Cyclophosphamide.
- Generate immuno-competent dendritic cells in conditions of Good Clinical Practice and Good Laboratory Practices.
- Determine in each patient the immunological status of specific T lymphocytes against tumor antigens, before and after chemotherapy, in order to demonstrate whether the adoptive transfer of DCs favors the anti-tumor immune response.
- Register in patients with breast cancer in neo-adjuvant chemotherapy the class and frequency of adverse effects that could be generated as a result of the adoptive transfer of autologous DCs.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Biological: Dendritic cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of Autologous Dendritic Cells in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy.|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||August 2018|
Transfer of autologous dendritic cells interspersed with chemotherapy doses
Biological: Dendritic cells
Adoptive transfer of autologous DCs
No Intervention: Control
Control patients who follow their basic treatment with chemotherapy with the A/C scheme
- Adverse effects [ Time Frame: One year after innoculation ]Number of participants with treatment-related adverse events as associated with DCs inoculation assessed by CTCAE v4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450044
|Fundación Salud de los Andes|
|Bogota, Cundinamarca, Colombia, 111321|
|Study Chair:||Fabio Méndez, MD||CEO|