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Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Database: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03275311
Acronym
ESME-MBC
Enrollment
42000
Registered
2017-09-07
Start date
2014-07-01
Completion date
2027-12-01
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer, observational study, survival, real world data, real life setting

Brief summary

The Epidemiological Strategy and Medical Economic (ESME) Breast cancer Database is a multicenter real life database using a retrospective data collection process across 18 French comprehensive cancer centers (FCCC) spread over 20 sites. This database compiles data from patient's electronic medical records (EMR).

Detailed description

This database compiles existing data retrieved fromp patient's electronic medical records (EMR) across the 18 French comprehensive cancer centers spread over 20 sites. . The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool. Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients. Cases selected to enter the ESME MBC data platform fulfill specific criteria: (1) Male or female ≥18 years old (2) metastatic breast cancer (3) with first metastasis treated (either completely or partially) at a participating site from January 2008 onwards.Treatment strategies considered include radiotherapy, chemotherapy, targeted therapy and endocrine therapy.

Interventions

None listed

Sponsors

UNICANCER
Lead SponsorOTHER
Roche Pharma AG
CollaboratorINDUSTRY
Pierre Fabre Laboratories
CollaboratorINDUSTRY
Pfizer
CollaboratorINDUSTRY
AstraZeneca
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Eisai Inc.
CollaboratorINDUSTRY
Daiichi Sankyo
CollaboratorINDUSTRY
Eli Lilly and Company
CollaboratorINDUSTRY
Gilead Sciences
CollaboratorINDUSTRY
Seagen Inc.
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

: * 18 years old patient * Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.

Exclusion criteria

: None

Design outcomes

Primary

MeasureTime frameDescription
Describe the evolution of therapeutic carebaselinePatient characteristics, tumor characteristics and treatment patterns

Secondary

MeasureTime frameDescription
Describe the impact of therapeutic strategies on survival criteriaFrom date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2023.Overall survival

Countries

France

Contacts

CONTACTLise Bosquet, MsC
l-bosquet@unicancer.fr
CONTACTMathieu Robain, MD, PhD
m-robain@unicancer.fr
STUDY_DIRECTORLise Bosquet, MsC

UNICANCER

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026