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NCT Number: NCT05981326

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood samples and questionnaires
  • 18 years old or at time of written consent
  • Patient with histologically confirmed breast cancer
  • Absence of metastatic disease
  • Patient requiring neoadjuvant chemotherapy
  • Performance status ≤ 2 (according to WHO criteria)
  • Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Patient must be affiliated to a Social Health Insurance
  • For patients taking part in the RTW WP: working patients at time of diagnostic and in sick leave at time of inclusion

Exclusion criteria

  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
  • Non epithelial breast cancer
  • Coagulopathy or other pathology that contraindicates biopsy procedures
  • Pregnant or nursing patient
  • Individual deprived of liberty or placed under the authority of a tutor
  • Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
  • For patients taking part in the RTW WP: patient in an "self employed" or "interim" employment situation
  • For patients taking part in the RTW WP: Patients working part-timeProcedures for withdrawal of incorrectly enrolled patients are presented in Section 7.5.

Treatment and study plan

Biopsy

Procedure

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

Blood samples

Procedure

Centralized blood samples will be performed at inclusion + evaluation visits

Questionnaires

Behavioral

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

Primary outcomes

  1. The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy

    Time frame: 6 months after the initiation of neoadjuvant chemotherapy

    The primary endpoint is the predictive yield of complete pathological response (pCR) after the neoaduvant treatment

  2. To determine the rate of Event Free Survival

    Time frame: 5 years after the initiation of treatment

    The primary endpoint is the predictive yield of Event Free Survial up to 5 years

  3. To determine the rate of Overall Survival

    Time frame: 5 years after the initiation of treatment

    The primary endpoint is the predictive yield of overall Survival up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Sebastien FRENEL, MD

CONTACT

[email protected]

+33240679900 ext. +33

Marine TIGREAT

CONTACT

[email protected]

+33240679878 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: NEOEPICURE

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Aug 8, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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