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Trial Title:
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
NCT ID:
NCT05981326
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Neo adjuvant chemotherapy
Multi omic analysis
Predilection in silico
Prospective clinico database
Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
biopsy will be performed for multi-omicanalysis at inclusion before initiation of
treatment
Arm group label:
cohort: ER/PR+ /HER2- breast cancer
Arm group label:
cohort: HER2+ breast cancer
Arm group label:
cohort: triple negative breast cancer
Intervention type:
Procedure
Intervention name:
Blood samples
Description:
Centralized blood samples will be performed at inclusion + evaluation visits
Arm group label:
cohort: ER/PR+ /HER2- breast cancer
Arm group label:
cohort: HER2+ breast cancer
Arm group label:
cohort: triple negative breast cancer
Intervention type:
Behavioral
Intervention name:
Questionnaires
Description:
Food inquiry + food-frequency questionnaire + physical activity questionnaire will be
performed at inclusion
Arm group label:
cohort: ER/PR+ /HER2- breast cancer
Arm group label:
cohort: HER2+ breast cancer
Arm group label:
cohort: triple negative breast cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Angers
Zip:
49055
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne PASTSOURIS, MD
Email:
anne.patsouris@ico.unicancer.fr
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean Sébastien FRENEL, MD
Email:
jean-sebastien@ico.unicancer.fr
Start date:
October 31, 2023
Completion date:
April 2033
Lead sponsor:
Agency:
Institut Cancerologie de l'Ouest
Agency class:
Other
Source:
Institut Cancerologie de l'Ouest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05981326
