GcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer

Phase 2

• Conditions: Metastatic hormone-receptor positive and HER2 negative breast cancer; Breast Neoplasms; Breast Diseases

• Registration Number: RPCEC00000220
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 286

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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