Status:
COMPLETED
Personalized Vaccine for Cancer Immunotherapy
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Fundación Salud de los Andes
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
Due to their genetic instability, breast tumors that do not express receptors for Estrogens, Progestagens or amplify the Her2 / neu oncogene \[called triple-negative breast cancer (TNTC)\] and other t...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of ductal cancer who enter the primary or neoadjuvant chemotherapy regimen treated with Doxorubicin or Cyclophosphamide.
- Patients with breast cancer with the HLA-A \* 02: 01 haplotype.
- Women of legal age who are not pregnant or breastfeeding (patients or controls).
- Patients who have histologically confirmed primary breast carcinoma of the ductal type.
- Karnofsky index greater than 70%
- Voluntary acceptance of informed consent.
Exclusion
- Patients with a diagnosis of triple-negative breast cancer.
- Pregnant patients
- Patients under age or over 70 years
- Patients diagnosed with autoimmune diseases
- The patient has a Karnofsky lower than 70% or an ECOG higher than 1.
- Patients who have received some therapy as a treatment for their tumor pathology (radiotherapy, chemotherapy, immunotherapy, or gene therapy).
- Active autoimmune disease requiring treatment or a history of autoimmune disease that could be exacerbated by treatment. Patients with endocrine disease controlled by replacement therapy, including thyroid disease, adrenal disease, and vitiligo, can be included.
- Presence of a chronic or acute infection, such as HIV, viral hepatitis, or tuberculosis, before or after signing the informed consent.
- Use of immunosuppressants within 4 weeks before the trial (e.g., corticosteroids), such as azathioprine, prednisone, or cyclosporine A. The use of local steroids (topical, nasal, or inhaled) may be acceptable.
- Clinically significant cardiomyopathy, which requires treatment.
- Splenectomized patients.
- Patients who do not receive the neoadjuvant chemotherapy regimen with Doxorubicin and cyclophosphamide for three cycles or receive some other type of complementary therapy such as taxanes.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04879888
Start Date
August 1 2016
End Date
July 30 2017
Last Update
May 10 2021
Active Locations (1)
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1
Facultad de Medicina - Universidad Nacional de Colombia
Bogota, Cundinamarca, Colombia, 111321