Breast CancerEPICURE_SEINNCT03958136
Clinico-biological Data Collection Study of Metastatic Breast Cancer
A study testing Metastasis biopsy, Biomarkers blood, urine and microbiota samples and Patient Reported Outcome (PRO) in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metastasis biopsy, Biomarkers blood, urine and microbiota samples and Patient Reported Outcome (PRO)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Dec 2018to 30 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cacerologie de l'ouest - site Paul Papin
Angers, 49055
Institut de cancerologie de l'Ouest
Saint-Herblain, 44805
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Breast Cancer
- Being tested
- Metastasis biopsy, Biomarkers blood, urine and microbiota samples, Patient Reported Outcome (PRO)
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastasis biopsyProcedure or surgery
Metastasis biopsy will be performed for multi-omic analysis
Biomarkers blood, urine and microbiota samplesBiological
Biomarkers blood, urine and microbiota samples for multi-omic analysis
Patient Reported Outcome (PRO)Behavioural
Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Procedure: Metastasis biopsy; Biological: Biomarkers blood, urine and microbiota samples; Behavioral: Patient Reported Outcome (PRO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of complex prospective clinico-biological database in metastatic breast cancer
specific metastatic biopsy intervention
Measured: 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
Measured: 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.
Measured: 15 years after inclusion
Secondary outcomes (7)
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
Measured: 15 years after inclusion
Quality of life during treatment
QLQ-C30 Questionnaire (total score)
Measured: every 4-6 months for 15 years after inclusion
Quality of life during treatment
BR23 Questionnaire (total score)
Measured: every 4-6 months for 15 years after inclusion
Quality of life during treatment
STAI anxiety Questionnaire (total score)
Measured: every 4-6 months for 15 years after inclusion
Quality of life during treatment
Beck Depression Inventory (BDI) (total score)
Measured: every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence
RECIST 1.1 or iRECIST assessment
Measured: every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence
biological assessment
Measured: every 4-6 months for 15 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start24 Dec 2018
- Primary completion24 Dec 2035 (estimated)
- Study completion30 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)
- Masking
- None (open label)
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, AstraZeneca, Novartis, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Mario CAMPONE, MD, PhD, Principal investigator, Institut de Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958136
- Sponsor's protocol ID
- ICO-N-2017-12
- Acronym
- EPICURE_SEIN
- Status last verified
- Jul 2025
- First submitted
- 31 Dec 2018
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33789635
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03958136
- Acronym / sponsor ID
- EPICURE_SEIN / ICO-N-2017-12
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- European Regional Development Fund, AstraZeneca, Novartis, Eli Lilly and Company
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 24 Dec 2035 (estimated)
- Study completion
- 30 Dec 2036 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)
| Arm | Type | Receives |
|---|---|---|
| Patients HR + and HER2- | Experimental | Procedure: Metastasis biopsy, Biological: Biomarkers blood, urine and microbiota samples, Behavioral: 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) |
| Patients HER2 + with or without HR+ | Experimental | Procedure: Metastasis biopsy, Biological: Biomarkers blood, urine and microbiota samples, Behavioral: 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) |
| Patients triple negative (HR- and HER2-) | Experimental | Procedure: Metastasis biopsy, Biological: Biomarkers blood, urine and microbiota samples, Behavioral: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metastasis biopsyMetastasis biopsy will be performed for multi-omic analysis | Procedure or surgery | Patients HER2 + with or without HR+, Patients HR + and HER2-, Patients triple negative (HR- and HER2-) |
| Biomarkers blood, urine and microbiota samplesBiomarkers blood, urine and microbiota samples for multi-omic analysis | Biological | Patients HER2 + with or without HR+, Patients HR + and HER2-, Patients triple negative (HR- and HER2-) |
| 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. | Behavioural | Patients HER2 + with or without HR+, Patients HR + and HER2-, Patients triple negative (HR- and HER2-) |
Primary outcome
Creation of complex prospective clinico-biological database in metastatic breast cancer
Time frame: At each progressive disease, 15 years after inclusion
specific metastatic biopsy intervention
Creation of complex prospective clinico-biological database in metastatic breast cancer
Time frame: At each progressive disease, 15 years after inclusion
search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management
Overall survival
Time frame: 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.
7 secondary outcomes
Progression free survival
Time frame: 15 years after inclusion
Quality of life during treatment
Time frame: every 4-6 months for 15 years after inclusion
Quality of life during treatment
Time frame: every 4-6 months for 15 years after inclusion
Quality of life during treatment
Time frame: every 4-6 months for 15 years after inclusion
Quality of life during treatment
Time frame: every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence
Time frame: every 4-6 months for 15 years after inclusion
Response to treatment for each therapeutic sequence
Time frame: every 4-6 months for 15 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 33789635Colombie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario CAMPONE, MD, PhD principal investigator
Institut de Cancerologie de l'Ouest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metastasis biopsy, Biomarkers blood, urine and microbiota samples and Patient Reported Outcome (PRO) in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of complex prospective clinico-biological database in metastatic breast cancer (time frame: At each progressive disease, 15 years after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.