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

Status: Recruiting

Location: See location...

Intervention Type: Other

Study Type: Interventional

Study Phase: Not Applicable

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)

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

⁃ 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.

Locations

Other Locations

France

Institut Universitaire du Cancer de Toulouse - Oncopole

RECRUITING

Toulouse

Contact Information

Primary

Florence DALENC, MD, Professor

Dalenc.Florence@iuct-oncopole.fr

+33 5311 55 104

Backup

Camille FRANCHET, MD

Franchet.Camille@iuct-oncopole.fr

+33 5 31 15 64 03

Time Frame

Start Date: 2026-02-06

Estimated Completion Date: 2035-02-06

Participants

Target number of participants: 1050

Treatments

Other: 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)

Other: 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)

Other: 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)

Related Therapeutic Areas

Breast Cancer

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