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

March 26, 2026 updated by: Institut Cancerologie de l'Ouest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood samples and questionnaires
  2. 18 years old or at time of written consent
  3. Patient with histologically confirmed breast cancer
  4. Absence of metastatic disease
  5. Patient requiring neoadjuvant chemotherapy
  6. Performance status ≤ 2 (according to WHO criteria)
  7. Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
  8. 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.
  9. Patient must be affiliated to a Social Health Insurance
  10. For patients taking part in the RTW WP: working patients at time of diagnostic and in sick leave at time of inclusion

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort: triple negative breast cancer

Standard drug: Neoadjuvant treatment : Weekly paclitaxel + carboplatin + pembrolizumab (TCP) followed by EC90 *4 pembrolizumab

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
Procedure: Biopsy
biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
Procedure: Blood samples
Centralized blood samples will be performed at inclusion + evaluation visits
Behavioral: Questionnaires
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
Experimental: cohort: HER2+ breast cancer

Standard drug:

EC100 followed by docetaxel + trastuzumab or EC100 followed by paclitaxel + trastuzumab Docetaxel + carboplatin + trastuzumab *6 folowed by trastuzumab alone

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
Procedure: Biopsy
biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
Procedure: Blood samples
Centralized blood samples will be performed at inclusion + evaluation visits
Behavioral: Questionnaires
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
Experimental: cohort: ER/PR+ /HER2- breast cancer

Standard drug: EC100 paclitaxel or EC100 docetaxel

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
Procedure: Biopsy
biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
Procedure: Blood samples
Centralized blood samples will be performed at inclusion + evaluation visits
Behavioral: Questionnaires
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after the initiation of neoadjuvant chemotherapy
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
5 years after the initiation of treatment
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
5 years after the initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Study Director: Jean Sebastien FRENEL, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2033

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2023-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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