Metastatic hormone-receptor positive and HER2 negative breast cancer
Conditions
Interventions
Group 1 (Experimental): Onco-specific treatment + NGcGm3/VSSP (900µg) subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 20 months
Antineoplastic Agents
Placebo
Injections, Subcutaneous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients with hormone-receptor positive and HER2-negative metastatic breast cancer, not previously treated for the metastatic disease. 2. Patients older than 18 years. 3. Patients who consent to participate in the study by signing the informed consent model. 4. Patients with ECOG scale of Performance Status = 2. 5. Patients who are not pregnant or breastfeeding. 6. Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3. 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 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 with brain metastases. 5. Patients with acute or chronic infectious diseases. 6. Patients with decompensated chronic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (Time from randomization until progression of metastatic disease, or death from any cause). Measuring time: 20 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (Time from randomization until death, from any cause). Measuring time: 20 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 20 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 20 months. The AE are defined by - Description of the AE (Name of the AE) - Intensity of the AE (mild, moderate, severe, life-threatening, death) - Causality relationship (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) 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 20 months | — |
Countries
Cuba
Contacts
Public ContactAliz Vega Rodríguez
Center of Molecular Immunology
Outcome results
None listed