NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000220
• Date of registration: 28/11/2016
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer
• Scientific title: Specific active immunotherapy with the vaccine NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer
• Date of first enrolment: 01/02/2017
• Target sample size: 286
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000220-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 2-3

Countries of recruitment

Cuba

Contacts

• Name: Braulio Mestre Fernandez
• Affiliation: National Institute of Oncology and Radiobiology

• Name: Aliz Vega Rodríguez
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion 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: 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.


Age minimum: 18 years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Diseases

Breast Neoplasms

Metastatic hormone-receptor positive and HER2 negative breast cancer

Intervention(s)

G(M3) Ganglioside

Adjuvants, Immunologic

Injections, Subcutaneous

Gangliosides

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
Group 2 (Control): Onco-specific treatment + placebo subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 20 months

NGcGM3/VSSP

Placebo

Proteolipids

Antineoplastic Agents

Primary Outcome(s)

Progression-free survival (Time from randomization until progression of metastatic disease, or death from any cause). Measuring time: 20 months.

Secondary Outcome(s)

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

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable