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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tumor biopsy

    Other intervention

    As fresh tumor material is required for laboratory analysis purposes (ESPRESSO technique), tumor biopsies will be performed specifically for this study.

Treatment groups

1,050 Participants
are divided into 3 treatment groups
Group A: Early breast cancer (triple negative, HER2+, luminal) with indication of neo-adjuvant treatmentOther 1 intervention
Group B: Early breast cancer (triple negative, HER2+, luminal) without indication of neo-adjuvant treatmentOther 1 intervention
Group C: De novo metastatic breast cancer (triple negative, HER2+, luminal)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Time frame
5 years for each participant
2

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

Time frame
5 years of each participant
3

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

Time frame
5 years for each participant

Other outcomes

Sponsors and contacts

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