Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
NEOEPICURE
1 other identifier
interventional
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Oct 2023
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2033
March 31, 2026
March 1, 2026
4.4 years
June 19, 2023
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The accurancy predictive parameters for complete pathological response (pCR) after 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
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
The primary endpoint is the predictive yield of overall Survival up to 5 years
5 years after the initiation of treatment
Study Arms (3)
cohort: triple negative breast cancer
EXPERIMENTALStandard 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
cohort: HER2+ breast cancer
EXPERIMENTALStandard 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
cohort: ER/PR+ /HER2- breast cancer
EXPERIMENTALStandard drug: EC100 paclitaxel or EC100 docetaxel Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite
Interventions
biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
Centralized blood samples will be performed at inclusion + evaluation visits
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
Eligibility Criteria
You may qualify if:
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood samples and questionnaires
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institut de Cancérologie de l'Ouest
Angers, 49055, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean Sebastien FRENEL, MD
Institut de Cancérologie de l'Ouest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2023
First Posted
August 8, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2033
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share