Breast cancer IIa, IIb and IIIa surgically treated with positive ganglia
Conditions
Interventions
Group I (study): It receives intramuscular immunizations of 0.2 mg of the NGcGM3/VSSP Montanide ISA 51 vaccine preparation. Immunizations will be performed every 14 days until the 5th immunization. Af
Vaccines
Injections, Intramuscular
Placebos
NGcGM3/VSSP/Montanide ISA
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Female patients with breast cancer IIa, IIb y IIIa surgically treated with positive ganglia and clinical disease-free following onco-specific treatment. 2.Patients who underwent first-line onco-specific therapy (surgery, chemotherapy, hormonal therapy and radiotherapy) according to treatment guides established in the country, and those who completed the different protocols in a time period between 4 and 8 weeks before inclusion. 3.Informed consent of the patient to participate in the research. 4.Performance Status according to WHO from 0 to 2. 5.Age >= 18 years. 6.Reproductive-age patients with confirmed negative pregnancy tests using adequate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods, or tubal ligation). 7.Determination of hormonal receptor (estrogens and progesterones), HER-1, HER-2/neu and 14F7 primary tumor expressions. This determination must be made using the surgical piece biopsy for diagnosis. 8.Patients with axillary dissection will only be eligible if 10 or more ganglia were ablated and examined.
Exclusion criteria
Exclusion criteria: 1.Patients who underwent onco-specific therapy and completed the different protocols within 4 weeks or more than 8 weeks before trial inclusion. 2.Patients with history of demyelinating or inflammatory disease of the peripheral or central nervous system. 3.Pregnancy or breastfeeding. 4.Patients with acute or chronic infectious diseases. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients with psychiatric diseases, unable to understand and sign the informed consent document. 7.Patients with autoimmune diseases or decompensated chronic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Episode-free survival. Measuring time: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Global survival time, quality of life, safety and immunogenicity, measuring time: 24 months | — |
Countries
Cuba
Contacts
Public ContactKirenia Perez Ramirez
Center of Molecular Immunology (CIM)
Outcome results
None listed