Immunogenicity and Safety of DCs in Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03450044
• Date of registration: 12/02/2018
• Prospective Registration: No
• Primary sponsor: Fundación Salud de los Andes
• Public title: Immunogenicity and Safety of DCs in Breast Cancer TEBICA
• Scientific title: Immunogenicity and Safety of Autologous Dendritic Cells in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy.
• Date of first enrolment: January 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03450044
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Colombia

Contacts

• Name: Fabio Méndez, MD
• Affiliation: CEO

Key inclusion & exclusion criteria

Inclusion criteria:

- Women between 30 and 65 years old.

- Patients who have histologically confirmed primary invasive ductal carcinoma of the
breast.

- Patients who, at the time of their evaluation, present a breast cancer with TNM
classification: IIA, IIB, IIIA, IIIB, IIIC or IV; in whom the breast-tumor
relationship is not satisfactory for the surgical procedure, so that they will receive
neo-adjuvant chemotherapy with Doxorubicin and Cyclophosphamide for at least 3 cycles.

- Patients who voluntarily agree to enter the proposed immunotherapy scheme.

- Absence of second malignant disease with the exception of a cervical carcinoma or a
treated basal cell carcinoma.

- Normal blood, kidney function and hepatic function (neutrophil count 1000 / mm3,
lymphocyte count 500 / mm3, hemoglobin 8mg / dl, and platelet count 150,000 / mm3,
serum creatinine 1.5mg / dl, BUN 50mg / dl, aminotransferases 2 times of normal value
and bilirubin 2.0mg / dl).

- Karnofsky higher than 70% or ECOG 0 to 1.

- Life expectancy greater than three months.

- Ability to understand informed consent.

- Have a weight greater than 50 Kilos at the time of apheresis.

Exclusion criteria:

- Patients who are pregnant or breast-feeding.

- Patients who have received some type of therapy as treatment for their tumor pathology
in the breast, prior to the start of the trial (radiotherapy, chemotherapy,
immunotherapy or gene therapy).

- Metastasis to the central nervous system at the time of inclusion in the study.

- Active autoimmune disease requiring treatment or history of autoimmune disease, which
could be exacerbated by treatment. Patients with endocrine disease controlled by
replacement therapy may be included, including thyroid disease, adrenal disease and
vitiligo.

- Presence of a chronic or acute infection, such as HIV, viral hepatitis or
tuberculosis, before or after the signing of the informed consent.

- Use of immunosuppressant within 4 weeks prior to the trial (eg corticosteroids), such
as azathioprine, prednisone or cyclosporine A. The use of local steroids (topical,
nasal or inhaled) may be acceptable.

- Patients with eczema, history of eczema or other eczematous skin disorders or those
with acute or chronic exfoliative skin condition (eg atopic dermatitis, burns,
impetigo, varicella zoster, severe acne or open wounds).

- Any disease that could interfere with the patient's ability to carry out the treatment
(eg, Crohn's disease, ulcerative colitis or active diverticulitis, severe respiratory,
cardiovascular, neurological, infectious disease or uncontrolled metabolic disease),
including diseases of the psychiatric type.

- Clinically significant cardiomyopathy, which requires treatment.

- Splenectomized patients.

- Patients who do not receive the neo-adjuvant chemotherapy regimen with Doxorubicin and
Cyclophosphamide for three cycles.

- Patients who have had an excisional biopsy.



Age minimum: 30 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer Female

Intervention(s)

Biological: Dendritic cells

Primary Outcome(s)

Adverse effects [Time Frame: One year after innoculation]

Secondary ID(s)

TEBICA-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad Nacional de Colombia

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)