NCT07233928

Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,050 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a translational, open-label, monocentric and prospective cohort study of participants with breast cancer aiming to create a combined ESPRESSO (= organelle properties) phenotype and spatial proteomics data collection encompassing four cohorts: * TN eBC = cohort A, * HER2+ eBC = cohort B, * Luminal eBC = cohort C, * dnMBC = cohort D. In total 1050 participants will be enrolled in the study. Laboratory analysis (including ESPRESSO technique) will be conducted on the biological specimen collected during this study. The primary objective is to describe the amount of fatty acids accumulated in lipid droplets, within the four cohorts. As a secondary objective, the analysis will expand to other organelles like lysosomal acidity and nuclear organization. The study is due to last 9 years (4 years of recruitment and 5 years of study participation)

Detailed description

The study targets participants with early breast cancer (eBC) or de novo metastatic breast cancer (dnMBC) who will be treated within a standard of care procedure or a clinical trial. Following informed consent form signature, participants will be included in the study protocol and will be assigned in one of four cohorts, depending on the immunohistochemical subtype of tumor. Patients will be enrolled concomitantly in each cohort, with the following recruitment goals: * Cohort A (N = 300 patients): Triple Negative eBC (TN eBC) * Cohort B (N = 300 patients): HER2+ eBC (HR+ or HR-) * Cohort C (N = 300 patients): Luminal eBC (Luminal A or B) * Cohorte D (N = 150 patients): dnMBC of any subtype (TN, HER2+ or Luminal). After the cancer treatment completion, the participants will remain in the study for a follow-up period (study participation will be 5 years maximum since baseline). In this study, anti-cancer procedures or treatments, whatever they are, will not be under investigation; they will be performed, administrated and dosed according to the standard of care or according to the study protocol (if participation in a clinical trial). For each included participant, biological specimen (fresh tumor sample, blood samples, ascite or pleural fluids if applicable) will be collected. Depending on participant's cohort and treatment strategy (i.e. eBC with indication of neoadjuvant treatment or not, dnMBC with indication of surgical treatment or not), samples will be collected at different times points.

Conditions

• Early Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
OTHER	Tumor biopsy	As fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study.

Timeline

• Start date: 2026-02-06
• Primary completion: 2035-02-06
• Completion: 2035-02-06
• First posted: 2025-11-18
• Last updated: 2026-02-10

Locations

1 site across 1 country: France