Evaluation of a Novel Technique for the Discovery of New, Tumor-specific Targets for the Deployment of Innovative Immunotherapeutics Against Cancer.

Not Applicable

• Conditions: Estrogen Receptor Positive Breast Cancer
• Interventions: Procedure: Tumor resection

• Registration Number: NCT06629233
• Lead Sponsor: University Ghent

Brief Summary

The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors.

The main goal it aims to achieve is:

To discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. These new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects.

Participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. Part of these tissues will be used for this clinical research.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-25
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-04-14
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Female
• Minimally 18 years old
• Diagnosed with estrogen-receptor positive breast cancer
• This must be a primary tumor

Exclusion Criteria

• Male
• Younger than 18 years old
• Previous history of other tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of care tumor resection	Tumor resection	-

Primary Outcome Measures

Name	Time	Method
Discovery of new, tumor-specific, glycopeptide epitopes.	The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.	The discovery of new antigens, comprising both glycan and peptide (=glycopeptide), on the outside of the plasma membrane of the breast cancer cells. These antigens should be absent on healthy cells. These new, glycopeptide antigens can be used as target for immunotherapeutics against cancer.

Trial Locations

Locations (2)

AZ Maria Middelares; 🇧🇪 Ghent, East-Flanders, Belgium

University Hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium