Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

Recruiting

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT03275311
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Status Verified: 2024-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the evolution of therapeutic care	baseline	Patient characteristics, tumor characteristics and treatment patterns

Secondary Outcome Measures

Name	Time	Method
Describe the impact of therapeutic strategies on survival criteria	From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2023.	Progression free survival

Trial Locations

Locations (20)

Institut Bergonié; 🇫🇷 Bordeaux, France

Institut de Cancérologie de l'Ouest - Paul Papin; 🇫🇷 Angers, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont-ferrand, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Georges-François Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Institut régional du Cancer Montpellier / Val d'Aurelle; 🇫🇷 Montpellier, France

Institut de cancérologie de l'Ouest - René Gauducheau; 🇫🇷 Nantes, France

Institut Curie; 🇫🇷 Paris, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut Curie - Hôpital René Huguenin; 🇫🇷 Saint-Cloud, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Institut de Cancérologie de Lorraine; 🇫🇷 Nancy, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Jean Godinot; 🇫🇷 Reims, France