Metastatic triple negative breast cancer
Conditions
Interventions
Group 1 (experimental): Oncospecific treatment + NGcGm3 / VSSP (900µg) subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 24 month
Antibodies, Monoclonal, Humanized
Antineoplastic Agents
Injections, Subcutaneous
Administration, Intravenous
NGcGM3/VSSP,
Nimotuzumab
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Female patients with metastatic triple negative breast cancer. 2.Patients who are candidates for treatment with first-line chemotherapy for metastatic disease. 3.Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3 and EGFR. 4.Patients older than 18 years. 5.Patients who consent to participate in the study by signing the informed consent model. 6.Patients with ECOG scale of Performance Status = 2. 7.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.
Exclusion criteria
Exclusion criteria: 1.Patients who have been treated with NGcGm3 / VSSP or Nimotuzumab within 6 months prior to inclusion. 2.Patients who have been included in another clinical trial within 6 months prior to inclusion. 3.Patients with inflammatory carcinoma of the breast. 4.Patients who are pregnant or breastfeeding. 5.Patients with brain metastases. 6.Patients with acute or chronic infectious diseases. 7.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine or mAb. 8.Patients with autoimmune diseases. 9.Patients with descompensated chronic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (Time from the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response variables: Progression-free survival (Time from the date of randomization of the patient to date of progression of metastatic disease, or death from any cause). Measuring time: 24 months. Antitumor response (RECIST (version 1.1) scale). Measuring time: After completed the third cycle and the sixth cycle of first-line chemotherapy for metastatic disease, and then every 4 months up to 24 months. Quality of life (Questionnaires EORTC QLQ-C30 (cancer), EORTC QLQ-BR23 (breast cancer), and EORTC QLQ-BM22 (patients with bone metastases) . Measuring time: At baseline, and at 6, 9, 15 and 24 months Immune response variables: IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, Third (85), Sixth (169), Twelfth (337) days Recognition and lytic capacity of IgM and IgG antibodies induced by vaccination and directed to NGcGM3 on tumor lines expressing ganglioside (flow cytometry). Measuring time: At baseline, Third (85), Sixth (169), Twelfth (337) days Safety variables: Adverse Events (AE). Measuring time: Time of evaluation: every 3 months until 24 months Description of the AE (Name of the AE) Intensity of the AE (mild, moderate, severe, life-threatening, death) Relationship causality (very probable, probable, possible, unlikely, not related, not evaluable ) Gravity (serious, non serious) Previous knowledge (expected, non expected) Result (recovered, improved, sequelae, death ) Treatment (none, medication, surgical procedure, transfusion, other) | — |
Countries
Cuba
Contacts
Public ContactAliz Vega Rodríguez
Center of Molecular Immunology
Outcome results
None listed