Status:
RECRUITING
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 bre...
Eligibility Criteria
Inclusion
- 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)
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05981326
Start Date
October 31 2023
End Date
April 1 2033
Last Update
August 2 2024
Active Locations (2)
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1
Institut de Cancérologie de l'Ouest
Angers, France, 49055
2
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805