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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Sebastien FRENEL, MD | Contact | +33240679900 | +33 | jean-sebastien.frenel@ico.unicancer.fr |
| Marine TIGREAT | Contact | +33240679878 | +33 | marine.tigreat@ico.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean Sebastien FRENEL, MD | Institut de Cancérologie de l'Ouest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Recruiting | Angers | 49055 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
|
| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | 44805 | France |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D011677 | Punctures |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |