GcGM3/VSSP/Montanide ISA 51 vaccine for breast cancer IIa, IIb and IIIa surgically treated with positive ganglia and disease-free, Phase IIb/III.

Phase 2

Recruiting

• Conditions: Breast Neoplasms; Breast cancer IIa, IIb and IIIa surgically treated with positive ganglia; Breast Diseases

• Registration Number: RPCEC00000070
• 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: Recruiting
• Sex: Female
• Target Recruitment: 744

Inclusion Criteria

1.Female patients with breast cancer IIa, IIb y IIIa surgically treated with positive ganglia and clinical disease-free following onco-specific treatment. 2.Patients who underwent first-line onco-specific therapy (surgery, chemotherapy, hormonal therapy and radiotherapy) according to treatment guides established in the country, and those who completed the different protocols in a time period between 4 and 8 weeks before inclusion. 3.Informed consent of the patient to participate in the research. 4.Performance Status according to WHO from 0 to 2. 5.Age >= 18 years. 6.Reproductive-age patients with confirmed negative pregnancy tests using adequate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods, or tubal ligation). 7.Determination of hormonal receptor (estrogens and progesterones), HER-1, HER-2/neu and 14F7 primary tumor expressions. This determination must be made using the surgical piece biopsy for diagnosis. 8.Patients with axillary dissection will only be eligible if 10 or more ganglia were ablated and examined.

Exclusion Criteria

1.Patients who underwent onco-specific therapy and completed the different protocols within 4 weeks or more than 8 weeks before trial inclusion. 2.Patients with history of demyelinating or inflammatory disease of the peripheral or central nervous system. 3.Pregnancy or breastfeeding. 4.Patients with acute or chronic infectious diseases. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients with psychiatric diseases, unable to understand and sign the informed consent document. 7.Patients with autoimmune diseases or decompensated chronic diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episode-free survival. Measuring time: 24 months

Secondary Outcome Measures

Name	Time	Method
Global survival time, quality of life, safety and immunogenicity, measuring time: 24 months