Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT06195618
Eligibility Criteria:
Inclusion Criteria:
1. Be between 18 and 75 years of age.
2. Histologically confirmed diagnosis of primary triple negative breast carcinoma (TNBC).
3. Patients who have already been treated, either with chemo/radiotherapy and/or surgery regimens, and in whom, according to previous preclinical studies, it was possible to clearly identify tumor NEOANTIGENS expressed by their tumor.
4. Have frank venous access.
5. Have a functional status (Karnofsky Scale) greater than 70%.
6. Weight equal to or greater than 50 kilograms.
7. The chemical synthesis of at least one tumor NEOANTIGEN expressed exclusively by your tumor was successful.
8. The apheresis procedure successfully allowed the obtaining of sufficient white blood cells to obtain leukocytes necessary for functional tests and for the derivation of dendritic cells.
Exclusion Criteria:
1. Active and/or uncontrolled cardiovascular disease.
2. You are pregnant or breastfeeding.
3. Has associated medical comorbidities such as diabetes or kidney failure, or coagulation disorders.
4. You have been hospitalized in the last month.
5. Has another active primary tumor except for skin tumors.
6. Patients who are linked to another clinical study.
7. Patients with a history of infectious diseases such as HIV, Hepatitis, tuberculosis.
8. Consumption of immunosuppressive medications such as corticosteroids (except topical).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06195618
Study Brief:
Protocol Section:
NCT06195618