Clinico-biological Data Collection Study of Metastatic Breast Cancer

NCT03958136 | Active Not Recruiting

• 1 other identifier: ICO-N-2017-12
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Creation of complex prospective clinico-biological database in metastatic breast cancer

  specific metastatic biopsy intervention

  At each progressive disease, 15 years after inclusion

• Creation of complex prospective clinico-biological database in metastatic breast cancer

  search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management

  At each progressive disease, 15 years after inclusion

• Overall survival

  Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored.

  15 years after inclusion

Secondary Outcomes (7)

• Progression free survival

  15 years after inclusion

• Quality of life during treatment

  every 4-6 months for 15 years after inclusion

• Quality of life during treatment

  every 4-6 months for 15 years after inclusion

• Quality of life during treatment

  every 4-6 months for 15 years after inclusion

• Quality of life during treatment

  every 4-6 months for 15 years after inclusion

Study Arms (3)

Patients HR + and HER2-

EXPERIMENTAL

At each disease progression, patient will have specific interventions : * Metastasis biopsy * Biomarkers blood, urine and microbiota samples * Patient Reported Outcome (PRO)

Procedure: Metastasis biopsy; Biological: Biomarkers blood, urine and microbiota samples; Behavioral: Patient Reported Outcome (PRO)

Patients HER2 + with or without HR+

EXPERIMENTAL

At each disease progression, patient will have specific interventions : * Metastasis biopsy * Biomarkers blood, urine and microbiota samples * Patient Reported Outcome (PRO)

Procedure: Metastasis biopsy; Biological: Biomarkers blood, urine and microbiota samples; Behavioral: Patient Reported Outcome (PRO)

Patients triple negative (HR- and HER2-)

EXPERIMENTAL

At each disease progression, patient will have specific interventions : * Metastasis biopsy * Biomarkers blood, urine and microbiota samples * Patient Reported Outcome (PRO)

Procedure: Metastasis biopsy; Biological: Biomarkers blood, urine and microbiota samples; Behavioral: Patient Reported Outcome (PRO)

Interventions

Metastasis biopsy PROCEDURE

Metastasis biopsy will be performed for multi-omic analysis

Patients HER2 + with or without HR+; Patients HR + and HER2-; Patients triple negative (HR- and HER2-)

Biomarkers blood, urine and microbiota samples BIOLOGICAL

Biomarkers blood, urine and microbiota samples for multi-omic analysis

Patients HER2 + with or without HR+; Patients HR + and HER2-; Patients triple negative (HR- and HER2-)

Patient Reported Outcome (PRO) BEHAVIORAL

Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Patients HER2 + with or without HR+; Patients HR + and HER2-; Patients triple negative (HR- and HER2-)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• European Regional Development Fund: collaborator
• AstraZeneca: collaborator
• Novartis: collaborator
• Eli Lilly and Company: collaborator

Study Sites (2)

Institut de Cacerologie de l'ouest - site Paul Papin

Angers, 49055, France

Location

Institut de cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

Related Publications (1)

• Colombie M, Jezequel P, Rubeaux M, Frenel JS, Bigot F, Seegers V, Campone M. The EPICURE study: a pilot prospective cohort study of heterogeneous and massive data integration in metastatic breast cancer patients. BMC Cancer. 2021 Mar 31;21(1):333. doi: 10.1186/s12885-021-08060-8.

  PMID: 33789635 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Urination; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Mario CAMPONE, MD, PhD

  Institut de Cancerologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: May 21, 2019
• Study Start: December 24, 2018
• Primary Completion (Estimated): December 24, 2035
• Study Completion (Estimated): December 30, 2036
• Last Updated: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)