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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Metastasis biopsy

Biomarkers blood, urine and microbiota samples

Patient Reported Outcome (PRO)

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Patients HR + and HER2-

Patients HER2 + with or without HR+

Patients triple negative (HR- and HER2-)

Arm Description

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

Outcomes

Primary Outcome Measures

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

specific metastatic biopsy intervention

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

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

Overall survival

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

Secondary Outcome Measures

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

Quality of life during treatment

QLQ-C30 Questionnaire (total score)

Quality of life during treatment

BR23 Questionnaire (total score)

Quality of life during treatment

STAI anxiety Questionnaire (total score)

Quality of life during treatment

Beck Depression Inventory (BDI) (total score)

Response to treatment for each therapeutic sequence

RECIST 1.1 or iRECIST assessment

Response to treatment for each therapeutic sequence

biological assessment

Full Information

NCT ID

NCT03958136

First Posted

December 31, 2018

Last Updated

July 31, 2023

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

European Regional Development Fund, AstraZeneca, Novartis, Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03958136

Brief Title

Clinico-biological Data Collection Study of Metastatic Breast Cancer

Acronym

EPICURE_SEIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 24, 2018 (Actual)

Primary Completion Date

December 24, 2035 (Anticipated)

Study Completion Date

December 30, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

Collaborators

European Regional Development Fund, AstraZeneca, Novartis, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients HR + and HER2-

Arm Type

Experimental

Arm Description

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

Arm Title

Patients HER2 + with or without HR+

Arm Type

Experimental

Arm Description

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

Arm Title

Patients triple negative (HR- and HER2-)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Metastasis biopsy

Intervention Description

Metastasis biopsy will be performed for multi-omic analysis

Intervention Type

Biological

Intervention Name(s)

Biomarkers blood, urine and microbiota samples

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Patient Reported Outcome (PRO)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

specific metastatic biopsy intervention

Time Frame

At each progressive disease, 15 years after inclusion

Title

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

Description

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

Time Frame

At each progressive disease, 15 years after inclusion

Title

Overall survival

Description

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

Time Frame

15 years after inclusion

Secondary Outcome Measure Information:

Title

Progression free survival

Description

Progression Free survival is the delay between the first dose of a treatment sequence and the date of documented disease progression or death

Time Frame

15 years after inclusion

Title

Quality of life during treatment

Description

QLQ-C30 Questionnaire (total score)

Time Frame

every 4-6 months for 15 years after inclusion

Title

Quality of life during treatment

Description

BR23 Questionnaire (total score)

Time Frame

every 4-6 months for 15 years after inclusion

Title

Quality of life during treatment

Description

STAI anxiety Questionnaire (total score)

Time Frame

every 4-6 months for 15 years after inclusion

Title

Quality of life during treatment

Description

Beck Depression Inventory (BDI) (total score)

Time Frame

every 4-6 months for 15 years after inclusion

Title

Response to treatment for each therapeutic sequence

Description

RECIST 1.1 or iRECIST assessment

Time Frame

every 4-6 months for 15 years after inclusion

Title

Response to treatment for each therapeutic sequence

Description

biological assessment

Time Frame

every 4-6 months for 15 years after inclusion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mario CAMPONE, MD, PhD

Phone

+33240679900

Ext

9510

mario.campone@ico.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marine TIGREAT

Phone

+33240679900

Ext

9878

marine.tigreat@ico.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario CAMPONE, MD, PhD

Organizational Affiliation

Institut de Cancerologie de l'Ouest

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cacerologie de l'ouest - site Paul Papin

City

Angers

ZIP/Postal Code

49055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario CAMPONE, MD, PhD

Phone

+33240679900

Ext

9510

mario.campone@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Mario CAMPONE, MD, PhD

First Name & Middle Initial & Last Name & Degree

Anne PATSOURIS, MD

First Name & Middle Initial & Last Name & Degree

Caroline FONSEGRIVE, MD

First Name & Middle Initial & Last Name & Degree

Elouen BOUGHALEM, MD

First Name & Middle Initial & Last Name & Degree

Frederic BIGOT, MD

First Name & Middle Initial & Last Name & Degree

Julie VANBOCKSTAEL, MD

First Name & Middle Initial & Last Name & Degree

Paule AUGEREAU, MD

First Name & Middle Initial & Last Name & Degree

Patrick SOULIE, MD

First Name & Middle Initial & Last Name & Degree

Sophie ABADIE LACOURTOISIE, MD

Facility Name

Institut de cancerologie de l'Ouest

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario CAMPONE, MD, PhD

Phone

+33240679900

Ext

9510

mario.campone@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Mario CAMPONE, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jean Sebastien FRENEL, MD

First Name & Middle Initial & Last Name & Degree

Dominique BERTON-RIGAUD, MD

First Name & Middle Initial & Last Name & Degree

Emmanuelle BOURBOULOUX, MD

First Name & Middle Initial & Last Name & Degree

Marie ROBERT, MD

First Name & Middle Initial & Last Name & Degree

Carole GOURMELON, MD

First Name & Middle Initial & Last Name & Degree

Pauline DU RUSQUEC, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33789635

Citation

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.

Results Reference

derived

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Clinico-biological Data Collection Study of Metastatic Breast Cancer

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