RecruitingNot ApplicableNCT05981326

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


Sponsor

Institut Cancerologie de l'Ouest

Enrollment

300 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a database of early-stage breast cancer patients undergoing pre-surgery chemotherapy to develop computer models that can predict how well a patient's tumor will respond to treatment before it happens. Blood samples, biopsies, and questionnaires are collected during standard care. **You may be eligible if:** - You are 18 or older - You have been diagnosed with breast cancer confirmed by biopsy - Your cancer has not spread to distant organs - You need pre-surgery (neoadjuvant) chemotherapy as part of your standard treatment - You are willing to attend scheduled visits and provide samples **You may NOT be eligible if:** - You have another cancer that was treated in the last 5 years (except certain minor skin or cervical cancers) - You have non-epithelial breast cancer - You are pregnant or breastfeeding - You have a clotting disorder that makes biopsies unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy

biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment

PROCEDUREBlood samples

Centralized blood samples will be performed at inclusion + evaluation visits

BEHAVIORALQuestionnaires

Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion


Locations(2)

Institut de Cancérologie de l'Ouest

Angers, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05981326


Related Trials