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

NCT07233928 | Recruiting

• 1 other identifier: 25SEIN08
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Early Breast Cancer; Metastatic Breast Cancer

Keywords

breast cancer; organelle; lipid droplets; protein expression atlas and heterogeneity; metabolism

Outcome Measures

Primary Outcomes (1)

• The amount of fatty acids accumulated in lipid droplets, quantified by the total intensity of a lipid-droplet specific fluorescent dye in the four cohorts

  5 years for each participant

Secondary Outcomes (3)

• Pathological response will be assessed using residual cancer burden (RCB) index 17

  5 years for each participant

• Event-free survival (EFS) is defined as the time from inclusion until relapse (local, regional or distant) or death from any cause for eBC.

  5 years of each participant

• First line Progression-free survival (PFS1) is defined as the time from inclusion until progression or death from any cause for dnMBC

  5 years for each participant

Study Arms (3)

Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatment

OTHER

* The following samples will be collected during the study : * Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st recurrence * Blood samples at: baseline, mid-course of neo-adjuvant treatment, before and after surgery, end of systemic adjuvant treatment, every 6 or 12 months until the 1st recurrence or during 5 year follow-up period, following progressions/recurrences * Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: 1st recurrence, following progressions/recurrences * Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)

Other: Tumor biopsy

Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatment

OTHER

* The following samples will be collected during the study : * Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st recurrence * Blood samples at: baseline (= before surgery), after surgery, end of adjuvant chemotherapy, end of other systemic adjuvant treatment, every 6 or 12 months until the 1st recurrence or during 5 year follow-up period, following progressions/recurrences * Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: 1st recurrence, following progressions/recurrences * Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)

Other: Tumor biopsy

De novo metastatic breast cancer (triple negative, HER2+, luminal)

OTHER

* The following samples will be collected during the study : * Tumor sample (primitive tumor ± metastatic axillary lymph node) at: baseline, surgery, 1st progression * Blood samples at: baseline, 1st progression, following progressions * Ascite and pleural fluid (when a puncture procedure is performed for clinical purposes) at: baseline, 1st progression, following progressions * Data collection will be performed at baseline and then at each time point planned in the center for clinical standard of care assessment or clinical trial until end of participation (5 years from baseline at maximum). It will include tumor response and adverse event assessments (AE related to study procedures only)

Other: Tumor biopsy

Interventions

Tumor biopsy OTHER

As fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study.

De novo metastatic breast cancer (triple negative, HER2+, luminal); Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatment; Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (women or men) with histologically documented breast cancer
• Early Breast Cancer (eBC) or de novo metastatic BC (dnMBC), regardless the immunohistochemical subtype: Triple Negative BC (ER-negative \[\<10%\], PR-negative \[\<10%\] and HER2-negative \[i.e. null, ultra-low or low\] BC); HER2-positive BC: HER2 overexpression score 3+ or ERBB2 amplification whatever ER/PR expression and proliferation level; Luminal A-like BC: low to moderately proliferative (Ki67\<20%) ER-positive (≥ 10%) PR-positive (≥ 20%) BC and low proliferative (Ki67\< 14%) ER-positive PR-negative (\< 20%) BC; Luminal B-like BC: highly proliferative (Ki67≥ 20%) ER-positive, PR-positive BC or moderately proliferative (14% ≤ Ki67\< 20%) ER-positive PR-negative (\<20%) BC
• Age ≥ 18 years at the time of study entry
• Patient followed within a standard of care procedure or clinical trial
• ECOG performance status ≤ 2
• Breast cancer treatment not yet started
• Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
• Patient affiliated to a Social Health Insurance in France.

You may not qualify if:

• Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus.
• Abnormal coagulation contraindicating biopsy
• Previous or on going treatment for the breast cancer
• Bone metastases when this is the only site of biopsiable disease for dnMBC patients
• Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \< 8g/dl)
• Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Patient pregnant, or breast-feeding
• Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
• Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Florence DALENC, MD, Professor

CONTACT

+33 5311 55 104; Dalenc.Florence@iuct-oncopole.fr

Camille FRANCHET, MD

CONTACT

+33 5 31 15 64 03; Franchet.Camille@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be divided in 4 cohorts depending on the type of breast cancer (early stage \[eBC\] v. de novo metastatic \[dnMBC\]) and depending on the immunohistochemical subtype (triple negative, HER2+, luminal). The 4 cohorts will enroll independantly (in parallel). However, the sample collection schedule will differ depending on the treatment strategy. Three main treatment strategies have been identified: * Cohorts A, B and C (=early BC): with indication of neo-adjuvant treament * Cohorts A, B and C (=early BC): without indication of neo-adjuvant treatment * Cohort D (=dnMBC): metastatic treatment (with surgery if applicable)

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): February 6, 2035
• Study Completion (Estimated): February 6, 2035
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (1)