GcGM3/VSSP and nimotuzumab in patients with triple negative breast cancer

Phase 1

• Conditions: Metastatic triple negative breast cancer; Triple Negative Breast Neoplasms; Neoplasias de la Mama; Enfermedades de la Mama

• Registration Number: RPCEC00000218
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1.Female patients with metastatic triple negative breast cancer.
2.Patients who are candidates for treatment with first-line chemotherapy for metastatic disease.
3.Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3 and EGFR.
4.Patients older than 18 years.
5.Patients who consent to participate in the study by signing the informed consent model.
6.Patients with ECOG scale of Performance Status = 2.
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 or Nimotuzumab 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 who are pregnant or breastfeeding.
5.Patients with brain metastases.
6.Patients with acute or chronic infectious diseases.
7.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine or mAb.
8.Patients with autoimmune diseases.
9.Patients with descompensated chronic diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (Time from the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 24 months.<br><br><br><br>