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NCT Number: NCT03275311

Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Describe the evolution of therapeutic care

    Time frame: baseline

    Patient characteristics, tumor characteristics and treatment patterns

Secondary outcomes

  1. Describe the impact of therapeutic strategies on survival criteria

    Time frame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2023.

    Overall survival

  2. Describe the impact of therapeutic strategies on survival criteria

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Bosquet, MsC

CONTACT

[email protected]

Mathieu Robain, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ESME-MBC

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Sep 7, 2017
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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