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AzTrials

Metastatic Breast CancerESME-MBCNCT03275311

Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

An observational study of Metastatic Breast Cancer, run by UNICANCER at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
How many people
42,000 participants
Where
20 sitesFrance
Study dates
Jul 2014to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients treated for a metastatic breast cancer in a French Comprehensive Cancer Center over the selection period.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Bosquet, MsC contact

l-bosquet@unicancer.fr

Mathieu Robain, MD, PhD contact

m-robain@unicancer.fr

20 sites in 1 country

France20 sites, 20 recruiting

  • Institut de Cancérologie de l'Ouest - Paul Papin

    Angers, 49933

    Geneviève PERROCHEAU, +33 2 40 67 99 77, genevieve.perrocheau@ico.unicancer.fr

    Loïc CAMPION, loic.campion@ico.unicancer.fr

    Recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Anne JAFFRE, +33 5 56 33 78 48, a.jaffre@bordeaux.unicancer.fr

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Anne-Valérie GUIZARD, +33 2 31 45 52 45, av.guizard@baclesse.unicancer.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Marie-Ange MOURET-REYNIER, +33 4 73 27 81 37, marie-ange.mouret-reynier@clermont.unicancer.fr

    Recruiting

  • Centre Georges-François Leclerc

    Dijon, 21079

    Sandrine DABAYUKO, +33 45 34 80 67, SDabakuyo@cgfl.fr

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Marie-paule LEBITASY, +33 3 20 29 55 60, m-lebitasy@o-lambret.fr

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Thomas BACHELOT, +33 4 78 78 26 54, thomas.bachelot@lyon.unicancer.fr

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13273

    Lilian LABORDE, +33 4 91 22 35 10, LABORDEL@ipc.unicancer.fr

    Recruiting

  • Institut régional du Cancer Montpellier / Val d'Aurelle

    Montpellier, 34298

    Stéphanie DELAINE, +33 4 67 61 47 39, Stephanie.delaine@icm.unicancer.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Nancy

    Carine LAURENT, +33 3 83 59 83 32, c.laurent@nancy.unicancer.fr

    Recruiting

  • Institut de cancérologie de l'Ouest - René Gauducheau

    Nantes, 44805

    Geneviève PERROCHEAU, +33 2 40 67 99 77, genevieve.perrocheau@ico.unicancer.fr

    Loïc CAMPION, loic.campion@ico.unicancer.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Emmanuel CHAMOREY, +33 4 92 03 15 29, emmanuel.chamorey@nice.unicancer.fr

    Recruiting

  • Institut Curie

    Paris, 75005

    Etienne BRAIN, etienne.brain@curie.fr

    Recruiting

  • Institut Jean Godinot

    Reims, 51056

    Damien PARENT, +33 3 26 50 42 76, damien.parent@reims.unicancer.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Mathias BRETON, +33 2 99 25 32 67, m.breton@rennes.unicancer.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Agnès LOEB, +33 2 32 08 22 80, agnes.loeb@chb.unicancer.fr

    Recruiting

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, 92210

    Etienne BRAIN, +33 1 47 11 15 15, etienne.brain@curie.fr

    Recruiting

  • Centre Paul Strauss

    Strasbourg, 67065

    Michel VELTEN, +33 3 88 25 24 53, mvelten@strasbourg.unicancer.fr

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Delphine BERCHERY, 05 31 15 50 60, Berchery.Delphine@iuct-oncopole.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Valérie DEJEAN, +33 1 42 11 46 49, valerie.dejean@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official 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

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).

Read the 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.

Keywords
metastatic breast cancer, observational study, survival, real world data, real life setting
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe the evolution of therapeutic care

    Patient characteristics, tumor characteristics and treatment patterns

    Measured: baseline

Secondary outcomes (2)

  1. Describe the impact of therapeutic strategies on survival criteria

    Overall survival

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

  2. Describe the impact of therapeutic strategies on survival criteria

    Progression free survival

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2017
  2. Study startJul 2014
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
42,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03275311
Sponsor's protocol ID
ESMEMBC
Acronym
ESME-MBC
Status last verified
May 2026
First submitted
27 Jun 2017
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27436849

  • Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.

    PubMed 29655061

  • Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.

    PubMed 29660596

  • Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.

    PubMed 30357526

  • Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.

    PubMed 30539492

  • Delaloge S, Perol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572. No abstract available.

    PubMed 27831508

  • Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.

    PubMed 27986716

  • Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.

    PubMed 30744578

  • Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.

    PubMed 30796119

  • Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.

    PubMed 31087564

  • Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Levy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.

    PubMed 31330488

  • Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Goncalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CineBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.

    PubMed 31675683

  • 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.

    PubMed 31719684

  • Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.

    PubMed 31835235

  • Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.

    PubMed 32135312

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by UNICANCER at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Bosquet, MsC (l-bosquet@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the evolution of therapeutic care (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275311, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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