NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer. Phase II

Active specific immunotherapy with NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer patient treatment. Phase II.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000068

Enrollment

Registered

2010-12-17

Start date

2002-08-27

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Interventions

Study group (NGcGM3/VSSP/Montanide ISA 51 vaccine): The patients will receive a total of 15 administrations of the vaccine (0.2 mg/im) by intramuscular route. At the induction phase, patients will rec

G(M3) Ganglioside

Tamoxifen

Gangliosides

Proteolipids

N-Acetylneuraminic Acid

Adjuvants, Immunologic

Vaccines

Injections, Intramuscular

NAcGM3/VSSP/Montanide ISA

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with metastatic breast cancer (Stage IV or evolutive) with cito-histologic confirmation with the exception of bone lesions as the only site of metastases. 2.Patients who had finished their oncospecific treatment at least 4 weeks before entering the study. 3.Patients with signed informed consent. 4.Patients between 18 and 80 years old. 5.At least 6 months of life expectancy. 6.Patients with Performance Status between 0 and 2, according to WHO criteria (ECOG 0-2). 7.Laboratory parameters: a.-) Hb>=90g/L - Neutrophils .000/mm3 - Platelets >= 100 x 109 cells/Lb.-) Hepatics = 3 times upper normal limit - Bilirubin: 17 mol/L (LSN) - ALT: 40 U/L (LSN) - AST: 40 U/L (LSN) - Alkaline Phosphatase: 279 U/Lc.-) Creatinine ? 132 ?mol/L 8.Female patients.

Exclusion criteria

Exclusion criteria: 1.Patients with metastatic breast cancer (Stage IV or evolutive) suitable for oncospecific treatments not available in Cuba. 2.Patients who had received their oncospecific treatments within the 4 weeks before entering the study. 3.Patients who had finished their oncospecific treatment 6 months or longer before entering the study. 4.Pregnancy or breast feeding. 5.Brain metastases or history of inflamatory CNS diseases. 6.Previous malignant disease, except for cervix carcinoma in situ or non melanoma skin lesions. 7.Acute or cronic infectious diseases. 8.Patients with acute alergic states or history of severe alergic reactions. 9.Autoimmune diseases or uncontrolled cronic diseases. 10.Patients with as unique site of metastasis the contralateral breast.

Design outcomes

Primary

Measure	Time frame
Overall Survival, Time to Progression. Measuring time: Until patient death/ until disease progression	—

Secondary

Measure	Time frame
Immune response. Measuring time: 1 year Safety. Measuring time: Until patient death Clinical Response. Measuring time: until progression	—

Countries

Cuba

Contacts

Public ContactPatricia Marinello Erigolla.

Center of Molecular Immunology (CIM)

marinello@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026