Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 289
- 试验地点
- 2
- 主要终点
- Creation of complex prospective clinico-biological database in metastatic breast cancer
研究概览
简要总结
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.
PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.
详细描述
This prospective study will be conducted on first line metastatic breast cancer patients.
Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or breast tumor if local recurrence, usual treatment protocols are often guided by the following groups:
- Group 1 : Patients HR (Hormon Receptor) + (E (Estrogen Receptor) + and/or PR (Progesterone Receptor) +) and HER2- (Human Epidermal Growth Factor Receptor-2)
- Group 2 : Patients HER2 + with or without HR+
- Group 3 : Patients triple negative (HR- and HER2-) Patients will receive treatments as per standard care according to the patient group.
Standard treatments recommended for treatment first line are:
- For group 1 : For HR + and HER2- patients :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients HR + and HER2-
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Metastasis biopsy (Procedure)
Patients HR + and HER2-
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Biomarkers blood, urine and microbiota samples (Biological)
Patients HR + and HER2-
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Patient Reported Outcome (PRO) (Behavioral)
Patients HER2 + with or without HR+
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Metastasis biopsy (Procedure)
Patients HER2 + with or without HR+
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Biomarkers blood, urine and microbiota samples (Biological)
Patients HER2 + with or without HR+
At each disease progression, patient will have specific interventions :
- Metastasis biopsy
- Biomarkers blood, urine and microbiota samples
- Patient Reported Outcome (PRO)
干预措施: Patient Reported Outcome (PRO) (Behavioral)
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)
干预措施: Metastasis biopsy (Procedure)
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)
干预措施: Biomarkers blood, urine and microbiota samples (Biological)
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)
干预措施: Patient Reported Outcome (PRO) (Behavioral)
结局指标
主要结局
Creation of complex prospective clinico-biological database in metastatic breast cancer
时间窗: At each progressive disease, 15 years after inclusion
search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management
Overall survival
时间窗: 15 years after inclusion
Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored.
次要结局
- Quality of life during treatment(every 4-6 months for 15 years after inclusion)
- Response to treatment for each therapeutic sequence(every 4-6 months for 15 years after inclusion)
- Progression free survival(15 years after inclusion)