Breast CancerNEOEPICURENCT05981326
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
A study testing Biopsy, Blood samples and Questionnaires in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biopsy, Blood samples and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Oct 2023to Apr 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Anne PASTSOURIS, MD, anne.patsouris@ico.unicancer.fr
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Jean Sébastien FRENEL, MD, jean-sebastien@ico.unicancer.fr
About this study
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.
Read more
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
- Breast Cancer
- Being tested
- Biopsy, Blood samples, Questionnaires
- Keywords
- Neo adjuvant chemotherapy, Multi omic analysis, Predilection in silico, Prospective clinico database, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
Blood samplesProcedure or surgery
Centralized blood samples will be performed at inclusion + evaluation visits
QuestionnairesBehavioural
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
| Study group | Role | What they receive |
|---|---|---|
| cohort: triple negative breast cancer | Experimental | 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 Receives: Procedure: Biopsy; Procedure: Blood samples; Behavioral: Questionnaires |
| cohort: HER2+ breast cancer | Experimental | 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 Receives: Procedure: Biopsy; Procedure: Blood samples; Behavioral: Questionnaires |
| cohort: ER/PR+ /HER2- breast cancer | Experimental | Standard drug: EC100 paclitaxel or EC100 docetaxel
Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite Receives: Procedure: Biopsy; Procedure: Blood samples; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5 years after the initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start31 Oct 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Sebastien FRENEL, MD, Study director, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981326
- Sponsor's protocol ID
- ICO-2023-08
- Acronym
- NEOEPICURE
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05981326
- Acronym / sponsor ID
- NEOEPICURE / ICO-2023-08
- Conditions
- Breast Cancer
- Keywords
- Neo adjuvant chemotherapy, Multi omic analysis, Predilection in silico, Prospective clinico database, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort: triple negative breast cancer | Experimental | Procedure: Biopsy, Procedure: Blood samples, Behavioral: QuestionnairesStandard 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 | Experimental | Procedure: Biopsy, Procedure: Blood samples, Behavioral: QuestionnairesStandard 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 | Experimental | Procedure: Biopsy, Procedure: Blood samples, Behavioral: QuestionnairesStandard drug: EC100 paclitaxel or EC100 docetaxel Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsybiopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment | Procedure or surgery | cohort: ER/PR+ /HER2- breast cancer, cohort: HER2+ breast cancer, cohort: triple negative breast cancer |
| Blood samplesCentralized blood samples will be performed at inclusion + evaluation visits | Procedure or surgery | cohort: ER/PR+ /HER2- breast cancer, cohort: HER2+ breast cancer, cohort: triple negative breast cancer |
| QuestionnairesFood inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion | Behavioural | cohort: ER/PR+ /HER2- breast cancer, cohort: HER2+ breast cancer, cohort: triple negative breast cancer |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Sebastien FRENEL, MD study director
Institut de Cancérologie de l'Ouest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Blood samples and Questionnaires in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Sebastien FRENEL, MD (+33240679900 ext. +33, jean-sebastien.frenel@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy (time frame: 6 months after the initiation of neoadjuvant chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.