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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:
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)
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatment | Other |
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| Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatment | Other |
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| De novo metastatic breast cancer (triple negative, HER2+, luminal) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsy | Other | As fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire du Cancer de Toulouse - Oncopole | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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:
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| Other |
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Participants alive and relapse-free will be censored at last follow-up news or at initiation of new anticancer therapy |
| 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 | Participants alive and progression-free will be censored at last follow-up news or at initiation of new anticancer therapy | 5 years for each participant |
| D017437 |
| Skin and Connective Tissue Diseases |