Atlas of cell organelles and protein patterns in breast cancer subtypes
Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
This project will collect tumor and blood samples from people with early or newly metastatic breast cancer to test how much fat accumulates in tiny cell structures (lipid droplets) and to map protein patterns across tumor subtypes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1050 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT07233928 on ClinicalTrials.gov |
What this trial studies
This is a monocentric, prospective cohort project enrolling 1,050 participants divided into four cohorts by immunohistochemical subtype (triple negative, HER2+, luminal early breast cancer, and de novo metastatic breast cancer). Tumor biopsies and blood (and fluid when available) will be collected before treatment and analyzed using the ESPRESSO technique and spatial proteomics to quantify lipid droplets and other organelle properties. Treatments are given per standard of care or concurrent clinical trials and are not altered by participation. Participants will be followed for up to five years after baseline, with the overall project lasting about nine years to complete recruitment and follow-up.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically confirmed early breast cancer or de novo metastatic breast cancer who have not yet started cancer treatment and have ECOG performance status 0–2 are ideal candidates.
Not a fit: Patients who have already begun cancer therapy, have ECOG >2, or whose tumors are inaccessible for biopsy may not benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify organelle-based biomarkers or protein patterns that improve understanding of tumor biology and help guide future diagnostics or therapies.
How similar studies have performed: There is prior research using spatial proteomics and lipid droplet analysis in cancers, but applying the combined ESPRESSO organelle phenotype across large, subtype-specific cohorts is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Florence DALENC, MD, Professor
- Email: Dalenc.Florence@iuct-oncopole.fr
- Phone: +33 5311 55 104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.