Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05981326

Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients

Led by Institut Cancerologie de l'Ouest · Updated on 2026-03-31

300

Participants Needed

2

Research Sites

491 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases and 12,150 deaths estimated in 2018 . Two major achievements have been made in the last five years for breast cancer patients. The first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all BC subtypes. The second is conceptual with the generalization of adaptive therapeutic strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+, HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients completely redefined prognostic factors that were previously established with conventional approaches Pathological response remains a major prognostic factor especially for TNBC and HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant treatment and for patients with residual disease, the prognosis remains poor despite some adaptative strategies. Our project is to integrate massive and heterogeneous data concerning the disease (clinical and biological data, imaging and histological results (with multi-omics data)) and patient's environment, personal and familial history. These data are multiple and have dynamic interactions overtime. With the help of mathematical units with biological competences and scientific collaborations, our project is to improve the prediction of treatment response, based on clinical and molecular heterogeneous big data investigation. The main objective of this project is to set up a clinicobiological database prospectively by collecting prospective clinical, biological, pathological and multi-omic data from 300 Patients with early BC treated at the ICO in order to define an algorithm of individual decision for the prediction of the response to this treatment.

CONDITIONS

Official Title

Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained prior to any study procedures
  • Age 18 years or older at time of consent
  • Histologically confirmed breast cancer
  • No metastatic disease present
  • Planned neoadjuvant chemotherapy treatment
  • Performance status 2 or less (WHO criteria)
  • Any systemic therapy allowed alongside study per guidelines
  • Ability and willingness to comply with study protocol and visits
  • Affiliation to Social Health Insurance
  • For RTW subgroup: working at diagnosis and on sick leave at inclusion
Not Eligible

You will not qualify if you...

  • Other cancer treated within last 5 years (except non-melanoma skin cancer or cervical in situ carcinoma)
  • Non-epithelial breast cancer
  • Bleeding disorders or other reasons preventing biopsy
  • Pregnant or breastfeeding
  • Under legal custody or deprived of liberty
  • Unable to follow medical monitoring due to social, psychological, or geographical reasons
  • For RTW subgroup: self-employed or temporary work
  • For RTW subgroup: working part-time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Institut de Cancérologie de l'Ouest

Angers, France, 49055

Actively Recruiting

2

Institut de Cancérologie de l'Ouest

Saint-Herblain, France, 44805

Actively Recruiting

Loading map...

Research Team

J

Jean Sebastien FRENEL, MD

CONTACT

M

Marine TIGREAT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here