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

NCT ID: NCT07233928

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2035-01-05

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)

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

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

• 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)

Group Type: OTHER

Tumor biopsy

Intervention Type: OTHER

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

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

• 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)

Group Type: OTHER

Tumor biopsy

Intervention Type: 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)

• 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)

Group Type: OTHER

Tumor biopsy

Intervention Type: OTHER

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

Interventions

Tumor biopsy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient (women or men) with histologically documented breast cancer

2. 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

3. Age ≥ 18 years at the time of study entry

4. Patient followed within a standard of care procedure or clinical trial

5. ECOG performance status ≤ 2

6. Breast cancer treatment not yet started

7. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol

8. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria

1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus.

2. Abnormal coagulation contraindicating biopsy

3. Previous or on going treatment for the breast cancer

4. Bone metastases when this is the only site of biopsiable disease for dnMBC patients

5. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)

6. 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

7. Patient pregnant, or breast-feeding

8. 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.

9. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Countries

France

Central Contacts

Florence DALENC, MD, Professor

Role: CONTACT

Phone: +33 5311 55 104

Email: Dalenc.Florence@iuct-oncopole.fr

Camille FRANCHET, MD

Role: CONTACT

Phone: +33 5 31 15 64 03

Email: Franchet.Camille@iuct-oncopole.fr

Facility Contacts

Florence DALENC, MD, Professor

Role: primary

Role: backup

Other Identifiers

25SEIN08

Identifier Type: -

Identifier Source: org_study_id