Clinico-biological Data Collection Study of Metastatic Breast Cancer (EPICURE_SEIN)
Breast Cancer
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast cancer, first metastatic setting, prospective clinico-biological database, multi omic analysis, prediction in silico, overall survival, progression free survival, predictive factors, treatment response, resistance to cancer therapy, socio demographic profile
Eligibility Criteria
Inclusion Criteria:
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
- Women > 18 years old at time of written consent
- Patient with histologically confirmed breast cancer
- Breast cancer metastatic disease or locally advanced not eligible for local curative treatment intent with or without personal history of adjuvant therapy for this cancer (chemotherapy, radiotherapy, surgery …)
- Patient with metastases that can be biopsied.
- 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.
HR and HER2 status on metastatic sites or breast tumor if local recurrence:
For group 1 :
- Histologic and/or cytological confirmation of estrogen-receptor positive (ER+) and/ or progesterone receptor positive (PR+) breast cancer determined by local laboratory testing
- No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
For group 2 :
- Histologic and/or cytological confirmation of estrogen-receptor positive or negative and/ or progesterone receptor positive or negative breast cancer determined by local laboratory testing
- HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
For group 3 :
- Histologic and/or cytological confirmation of estrogen-receptor negative and progesterone receptor negative breast cancer determined by local laboratory testing
- No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
- Menopausal status : as per the institutional standard of care
- 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
Exclusion Criteria:
- Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
- Coagulopathy or other pathology that contraindicates biopsy procedures
- Prior systemic treatment in metastatic setting
- Patients with exclusive brain metastasis not available for surgery
- 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
Sites / Locations
- Institut de Cacerologie de l'ouest - site Paul PapinRecruiting
- Institut de cancerologie de l'OuestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Patients HR + and HER2-
Patients HER2 + with or without HR+
Patients triple negative (HR- and HER2-)
At each disease progression, patient will have specific interventions : Metastasis biopsy Biomarkers blood, urine and microbiota samples Patient Reported Outcome (PRO)
At each disease progression, patient will have specific interventions : Metastasis biopsy Biomarkers blood, urine and microbiota samples Patient Reported Outcome (PRO)
At each disease progression, patient will have specific interventions : Metastasis biopsy Biomarkers blood, urine and microbiota samples Patient Reported Outcome (PRO)