Early Breast CancerESPRESSOBREASTNCT07233928
Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
A study testing Tumor biopsy in people with Early Breast Cancer and Metastatic Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Tumor biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2026to 6 Feb 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
Florence DALENC, MD, Professor, +33531155104, Dalenc.Florence@iuct-oncopole.fr
Dalenc.Florence@iuct-oncopole.fr
About this study
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.
Read more
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)
Read the 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
- Being tested
- Tumor biopsy
- Keywords
- breast cancer, organelle, lipid droplets, protein expression atlas and heterogeneity, metabolism
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyOther
As fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years for each participant
Secondary outcomes (3)
Pathological response will be assessed using residual cancer burden (RCB) index 17
- RCB-0: pathologic complete response (pCR)
- RCB-I : minimal burden
- RCB-II: moderate burden
- RCB-III : extensive burden
Measured: 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.
Participants alive and relapse-free will be censored at last follow-up news or at initiation of new anticancer therapy
Measured: 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
Measured: 5 years for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start6 Feb 2026
- Primary completion6 Feb 2035 (estimated)
- Study completion6 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233928
- Sponsor's protocol ID
- 25SEIN08
- Acronym
- ESPRESSOBREAST
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
- ClinicalTrials.gov ID
- NCT07233928
- Acronym / sponsor ID
- ESPRESSOBREAST / 25SEIN08
- Conditions
- Early Breast Cancer, Metastatic Breast Cancer
- Keywords
- breast cancer, organelle, lipid droplets, protein expression atlas and heterogeneity, metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 6 Feb 2035 (estimated)
- Study completion
- 6 Feb 2035 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatment | Other | Other: Tumor biopsy* 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) |
| Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatment | Other | Other: Tumor biopsy* 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) |
| De novo metastatic breast cancer (triple negative, HER2+, luminal) | Other | Other: Tumor biopsy* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (9 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsyAs fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study. | Other | 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 |
Primary outcome
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
Time frame: 5 years for each participant
3 secondary outcomes
Pathological response will be assessed using residual cancer burden (RCB) index 17
Time frame: 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.
Time frame: 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
Time frame: 5 years for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy in people with Early Breast Cancer and Metastatic Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence DALENC, MD, Professor (+33 5311 55 104, Dalenc.Florence@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 years for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.