GcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer. Phase II

Phase 2

• Conditions: Metastatic Breast Cancer; Breast Neoplasms; Breast Diseases

• Registration Number: RPCEC00000068
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival, Time to Progression. Measuring time: Until patient death/ until disease progression

Secondary Outcome Measures

Name	Time	Method
Immune response. Measuring time: 1 year Safety. Measuring time: Until patient death Clinical Response. Measuring time: until progression