Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008
NCT ID: NCT03275311
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40000 participants
OBSERVATIONAL
2014-07-31
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Pierre Fabre Laboratories
INDUSTRY
Pfizer
INDUSTRY
AstraZeneca
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Eisai Inc.
INDUSTRY
Daiichi Sankyo
INDUSTRY
Eli Lilly and Company
INDUSTRY
Gilead Sciences
INDUSTRY
Seagen Inc.
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Lise Bosquet, MsC
Role: STUDY_DIRECTOR
UNICANCER
Locations
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Institut de Cancérologie de l'Ouest - Paul Papin
Angers, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges-François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Institut régional du Cancer Montpellier / Val d'Aurelle
Montpellier, , France
Institut de Cancérologie de Lorraine
Nancy, , France
Institut de cancérologie de l'Ouest - René Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut Curie - Hôpital René Huguenin
Saint-Cloud, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.
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Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.
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Carausu M, Carton M, Cabel L, Patsouris A, Levy C, Verret B, Pasquier D, Debled M, Goncalves A, Desmoulins I, Lecouillard I, Bachelot T, Ferrero JM, Eymard JC, Mouret-Reynier MA, Chevrot M, De Maio E, Uwer L, Frenel JS, Leheurteur M, Petit T, Darlix A, Bozec L. Clinicopathological characteristics and prognosis of breast cancer patients with isolated central nervous system metastases in the multicentre ESME database. Ther Adv Med Oncol. 2022 Feb 26;14:17588359221077082. doi: 10.1177/17588359221077082. eCollection 2022.
Dalenc F, Lusque A, De La Motte Rouge T, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Goncalves A, Desmoulins I, Levy C, Uwer L, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Frenel JS, Petit T, Chevrot M, Bachelot T, Guiu S. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022 Mar;164:70-79. doi: 10.1016/j.ejca.2021.12.031. Epub 2022 Feb 14.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESMEMBC
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Identifier Source: org_study_id
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