Actively Recruiting
Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
Led by Institut Claudius Regaud · Updated on 2026-02-10
1050
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying participants with early breast cancer or de novo metastatic breast cancer to create a combined ESPRESSO phenotype and spatial proteomics data collection across four groups based on tumor subtypes. This prospective, open-label study aims to understand fatty acid accumulation in lipid droplets and explore other organelle features like lysosomal acidity and nuclear organization. The study will last nine years, with four years of recruitment and five years of participation for each individual. Participants will be assigned to one of four cohorts depending on their tumor subtype: Triple Negative early breast cancer, HER2-positive early breast cancer, Luminal early breast cancer, or de novo metastatic breast cancer of any subtype. Biological samples such as fresh tumor biopsies, blood, ascitic fluid, or pleural fluid will be collected at multiple time points before, during, and after treatment as part of standard care or clinical trials. Tumor biopsies will be performed specifically for this study to provide fresh material needed for laboratory analysis using the ESPRESSO technique. During the study, data will be collected at baseline and throughout scheduled visits aligned with clinical care or trial assessments for up to five years. This includes tumor response and adverse events related to study procedures. Researchers will measure fatty acid levels in lipid droplets as the primary outcome and assess pathological response, event-free survival, and progression-free survival as secondary outcomes. Participants will be monitored regularly through blood samples and other biological specimen collection to support these evaluations.
CONDITIONS
Brief Title
Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient (women or men) with histologically documented breast cancer
- Early Breast Cancer (eBC) or de novo metastatic BC (dnMBC), regardless of immunohistochemical subtype
- Age 18 years or older at the time of study entry
- Patient followed within standard of care or clinical trial
- ECOG performance status 0 to 2
- Breast cancer treatment not yet started
- Patient able to participate and willing to give informed consent and comply with study protocol
- Patient affiliated to a Social Health Insurance in France
You will not qualify if you...
- Known history of positive test for Hepatitis B, Hepatitis C, HIV, or Hanta virus
- Abnormal coagulation contraindicating biopsy
- Previous or ongoing treatment for breast cancer
- Bone metastases as only biopsiable disease site for dnMBC patients
- Conditions contraindicating required blood sampling (including hemoglobin below 8g/dl)
- Known additional malignancy progressing or requiring active treatment (exceptions for certain skin or cervical cancers)
- Patient pregnant or breastfeeding
- Psychological, familial, geographic, or social situations preventing informed consent or compliance
- Patient under legal guardianship or deprived of freedom by administrative or legal decision
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to baseline visit
Participants provide tumor and blood samples before starting breast cancer treatment. Initial clinical assessments are performed.
1 visit (in-person)
Duration - Variable depending on treatment duration
Participants undergo standard of care or trial-based anti-cancer treatment according to their treatment strategy. Tumor biopsies and blood samples are collected at various points including mid-treatment, before and after surgery, and at treatment milestones.
Multiple visits depending on treatment schedule
Duration - Surgery day and immediate perioperative period
Participants undergoing surgery will have tumor samples collected at surgery time.
1 visit (in-person) around surgery
Duration - Up to 5 years from baseline
After cancer treatment completion, participants are followed for up to 5 years from baseline with periodic blood sample collections and clinical assessments to monitor for recurrence or progression.
Visits every 6 to 12 months during follow-up
Trial Site Locations
Total: 1 location
1
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059
Actively Recruiting
Research Team
F
Florence DALENC, MD, Professor
C
Camille FRANCHET, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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