Clinico-biological Data Collection Study of Metastatic Breast Cancer (EPICURE_SEIN)

Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Metastasis biopsy; Biological: Biomarkers blood, urine and microbiota samples; Behavioral: Patient Reported Outcome (PRO)

Detailed Description

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:

1. For group 1 : For HR + and HER2- patients :

   • For patients requiring Chemotherapy (visceral crisis), the recommended treatment is : Taxanes based chemotherapy Anthracyclines based chemotherapy
   • For the patients without visceral crisis: the recommended treatment is : Hormonal therapy combined with CDK 4-6 inhibitors (Cyclin-dependent kinase) as recommended in standard care.

2. For group 2 : HER2 + (with or without HR+), the recommended treatment is :

   • Paclitaxel (Taxol) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
   • Docetaxel (Taxotere) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.

3. For group 3 : triple negative (HR- and HER2-) patients, the recommended treatment is :

   • Paclitaxel (Taxol) with or without Bevacizumab (Avastin) as per the institutional standard of care.

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 6 months according to patient group.

Clinical, biological, pathological, epidemiological, socio-economic and multi-omic data will be collected throughout the study duration.

These massive data will be used to create new algorithms in order to help clinicians to predict treatment response.

• Study Type: Interventional
• Enrollment (Estimated): 289
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de Cacerologie de l'ouest - site Paul Papin
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
2. Women > 18 years old at time of written consent
3. Patient with histologically confirmed breast cancer
4. 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 …)
5. Patient with metastases that can be biopsied.
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. 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
9. Menopausal status : as per the institutional standard of care
10. 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.
11. Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
2. Coagulopathy or other pathology that contraindicates biopsy procedures
3. Prior systemic treatment in metastatic setting
4. Patients with exclusive brain metastasis not available for surgery
5. Pregnant or nursing patient
6. Individual deprived of liberty or placed under the authority of a tutor
7. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: Metastasis biopsy; Metastasis biopsy will be performed for multi-omic analysis; Biological: Biomarkers blood, urine and microbiota samples; Biomarkers blood, urine and microbiota samples for multi-omic analysis; Behavioral: Patient Reported Outcome (PRO); Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
Experimental: 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)	Procedure: Metastasis biopsy; Metastasis biopsy will be performed for multi-omic analysis; Biological: Biomarkers blood, urine and microbiota samples; Biomarkers blood, urine and microbiota samples for multi-omic analysis; Behavioral: Patient Reported Outcome (PRO); Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
Experimental: 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)	Procedure: Metastasis biopsy; Metastasis biopsy will be performed for multi-omic analysis; Biological: Biomarkers blood, urine and microbiota samples; Biomarkers blood, urine and microbiota samples for multi-omic analysis; Behavioral: Patient Reported Outcome (PRO); Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression Free survival is the delay between the first dose of a treatment sequence and the date of documented disease progression or death	15 years after inclusion
Quality of life during treatment	QLQ-C30 Questionnaire (total score)	every 4-6 months for 15 years after inclusion
Quality of life during treatment	BR23 Questionnaire (total score)	every 4-6 months for 15 years after inclusion
Quality of life during treatment	STAI anxiety Questionnaire (total score)	every 4-6 months for 15 years after inclusion
Quality of life during treatment	Beck Depression Inventory (BDI) (total score)	every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence	RECIST 1.1 or iRECIST assessment	every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence	biological assessment	every 4-6 months for 15 years after inclusion

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: Eli Lilly and Company; Novartis; AstraZeneca; European Regional Development Fund
• Investigators: Principal Investigator: Mario CAMPONE, MD, PhD, Institut de Cancérologie de l'Ouest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2018
• Primary Completion (Estimated): December 24, 2035
• Study Completion (Estimated): December 30, 2036

Study Registration Dates

• First Submitted: December 31, 2018
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; overall survival; treatment response; progression free survival; predictive factors; first metastatic setting; prospective clinico-biological database; multi omic analysis; prediction in silico; resistance to cancer therapy; socio demographic profile
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICO-N-2017-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No