Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

Metastatic Breast Cancer Clinical Trial

— ESME-MBC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03275311
• Other study ID #: ESMEMBC
• Status: Recruiting
• Start date: July 2014
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: UNICANCER
• Contact: Mathieu Robain, MD, PhD
• Email: m-robain[@]unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a multi-center real life database using a retrospective data collection process (18 FCCCs over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

Description:

This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

Patient Database: Patient-related data integrates data from non-structured sources (electronic medical records), such as patient medical records and reports of multidiscipline team meetings. It can provide information on patient demographics, primitive tumour, relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal reasons when applicable, and clinical events.

Treatment Database: Pharmacy records-related data is a structured database including all data pertaining to medications prescribed and dispensed by pharmacies within each French Comprehensive Cancer Centers (FCCC), specifically chemotherapy and co-prescriptions. It does not contain information on products that are prescribed or delivered outside of the center. From each center's pharmacy database, information on systemic treatment patterns (dates, pharmaceutical forms, treatment protocols, etc.) can be obtained.

Hospitalization Database: Hospitalisation-related data is a structured and systematic database that contains all medical data reported related to any hospitalisation in the FCCC, and is used to bill the French National Health Insurance Fund (Assurance Maladie). It provides information on patient entry and discharge dates as well as diagnostic and therapeutic procedures performed, including radiotherapy and surgery.

Data imported into the final database are controlled, recoded, and harmonized before import according to a 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 are exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

ESME MBC Data Platform aims to be a clinical and therapeutic database centralising existing and available data from different sources used in the FCCCs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38000
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
France	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

Sponsors (11)

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

Country where clinical trial is conducted

France, 

References & Publications (50)

Annonay M, Gauquelin L, Geiss R, Ung M, Cristol-Dalstein L, Mouret-Reynier MA, Goncalves A, Abadie-Lacourtoisie S, Francois E, Perrin C, Le Fel J, Lorgis V, Servent V, Uwer L, Jouannaud C, Leheurteur M, Joly F, Campion L, Courtinard C, Villacroux O, Petit — View Citation

Antoine A, Perol D, Robain M, Delaloge S, Lasset C, Drouet Y. Target trial emulation to assess real-world efficacy in the Epidemiological Strategy and Medical Economics metastatic breast cancer cohort. J Natl Cancer Inst. 2023 Aug 8;115(8):971-980. doi: 1 — View Citation

Bertho M, Fraisse J, Patsouris A, Cottu P, Arnedos M, Perol D, Jaffre A, Goncalves A, Lebitasy MP, D'Hondt V, Dalenc F, Ferrero JM, Levy C, Dabakuyo S, Rouzier R, Penault-Llorca F, Uwer L, Eymard JC, Breton M, Chevrot M, Thureau S, Petit T, Simon G, Frene — View Citation

Bringuier M, Carton M, Levy C, Patsouris A, Pasquier D, Debled M, Rigal O, Jacot W, Goncalves A, Desmoulins I, De La Motte Rouge T, Bachelot T, Ferrero JM, Eymard JC, Ung M, Mouret-Reynier MA, Petit T, Chevrot M, Uwer L, Courtinard C, Frenel JS, Vianzone — View Citation

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. O — View Citation

Cabel L, Carton M, Pistilli B, Dalenc F, Vanlemnens L, Levy C, Jacot W, Debled M, Loeb A, Hennequin A, De la Motte Rouge T, Laborde L, Laurent C, Chamorey E, Parent D, Petit T, Mouret-Reynier MA, Campone M, Perrocheau G, Labreveux C, Bachelot T, Robain M, — View Citation

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, Bo — View Citation

Carausu M, Carton M, Darlix A, Pasquier D, Leheurteur M, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Verret B, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lefeuvre-Plesse C, Petit T, Uwer L, Jouannaud C, Larrouquere L, Chevrot M, Courtina — View Citation

Carausu M, Carton M, Dieras V, Petit T, Guiu S, Goncalves A, Augereau P, Ferrero JM, Levy C, Ung M, Desmoulins I, Debled M, Bachelot T, Pistilli B, Frenel JS, Mailliez A, Chevrot M, Cabel L. Association of Endocrine Therapy for HR+/ERBB2+ Metastatic Breas — View Citation

Collet L, Eberst L, Ludovic G, Debled M, Hrab L, Mouret-Reynier MA, Desmoulins I, Goncalves A, Campone M, Ferrero JM, Brain E, Uwer L, Eymard JC, Dieras V, Simon G, Leheurteur M, Dalenc F, Vanlemmens L, Darlix A, Arnedos M, Bachelot T. Clinical outcome of — View Citation

Corbaux P, Lardy-Cleaud A, Alexandre M, Fontanilles M, Levy C, Viansone AA, Mailliez A, Debled M, Goncalves A, Le Du F, Lerebours F, Ferrero JM, Eymard JC, Mouret-Reynier MA, Petit T, Frenel JS, Dalenc F, Courtinard C, Chaix M, Bachelot T. Progression-fre — View Citation

Courtinard C, Gourgou S, Jacot W, Carton M, Guerin O, Vacher L, Bertaut A, Le Deley MC, Perol D, Marino P, Levy C, Uwer L, Perrocheau G, Schiappa R, Bachelot F, Parent D, Breton M, Petit T, Filleron T, Loeb A, Pelissier SM, Robain M, Delaloge S, Bellera C — View Citation

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 lo — View Citation

Dano D, Lardy-Cleaud A, Monneur A, Quenel-Tueux N, Levy C, Mouret-Reynier MA, Coudert B, Mailliez A, Ferrero JM, Guiu S, Campone M, de La Motte Rouge T, Petit T, Pistilli B, Dalenc F, Simon G, Lerebours F, Chabaud S, Bertucci F, Goncalves A. Metastatic in — View Citation

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, C — View Citation

de Calbiac O, Lusque A, Mailliez A, Bachelot T, Uwer L, Mouret-Reynier MA, Emile G, Jouannaud C, Goncalves A, Patsouris A, Dieras V, Leheurteur M, Petit T, Cottu P, Ferrero JM, D'Hondt V, Desmoulins I, Mourato-Ribeiro J, Martin AL, Frenel JS. Comparison o — View Citation

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, — View Citation

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. — View Citation

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 — View Citation

Ezzalfani M, Porcher R, Savignoni A, Delaloge S, Filleron T, Robain M, Perol D; ESME Group. Addressing the issue of bias in observational studies: Using instrumental variables and a quasi-randomization trial in an ESME research project. PLoS One. 2021 Sep — View Citation

Francois-Martin H, Lardy-Cleaud A, Pistilli B, Levy C, Dieras V, Frenel JS, Guiu S, Mouret-Reynier MA, Mailliez A, Eymard JC, Petit T, Ung M, Desmoulins I, Augereau P, Bachelot T, Uwer L, Debled M, Ferrero JM, Clatot F, Goncalves A, Chevrot M, Chabaud S, — View Citation

Frank S, Carton M, Dubot C, Campone M, Pistilli B, Dalenc F, Mailliez A, Levy C, D'Hondt V, Debled M, Vermeulin T, Coudert B, Perrin C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Patsouris A, Guesmia T, Bachelot T, Robain M, C — View Citation

Frasca M, Sabathe C, Delaloge S, Galvin A, Patsouris A, Levy C, Mouret-Reynier MA, Desmoulins I, Vanlemmens L, Bachelot T, Goncalves A, Perotin V, Uwer L, Frenel JS, Ferrero JM, Bouleuc C, Eymard JC, Dieras V, Leheurteur M, Petit T, Dalenc F, Jaffre A, Ch — View Citation

Frenel JS, Lusque A, Delaloge S, Ferrero JM, Bachelot T, Desmoulins I, Levy C, Eymard JC, Goncalves A, Patsouris A, Reynier MAM, Thery MJ, Petit T, Cabel L, Uwer L, Debled M, Chevrot M, Mailliez A, Jacot W, de La Motte Rouge T. Efficacy of front-line trea — View Citation

Gaillard T, Carton M, Mailliez A, Desmoulins I, Mouret-Reynier MA, Petit T, Leheurteur M, Dieras V, Ferrero JM, Uwer L, Guiu S, Goncalves A, Levy C, Debled M, Dalenc F, Patsouris A, Bachelot T, Eymard JC, Chevrot M, Conversano A, Robain M, Hequet D. De no — View Citation

Galvin A, Courtinard C, Bouteiller F, Gourgou S, Dalenc F, Jacot W, Arnedos M, Bailleux C, Dieras V, Petit T, Emile G, Dubray-Longeras P, Frenel JS, Bachelot T, Mailliez A, Brain E, Desmoulins I, Massard V, Patsouris A, Goncalves A, Grinda T, Delaloge S, — View Citation

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 — View Citation

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 To — View Citation

Grinda T, Antoine A, Jacot W, Blaye C, Cottu PH, Dieras V, Dalenc F, Goncalves A, Debled M, Patsouris A, Mouret-Reynier MA, Mailliez A, Clatot F, Levy C, Ferrero JM, Desmoulins I, Uwer L, Petit T, Jouannaud C, Lacroix-Triki M, Deluche E, Robain M, Courtin — View Citation

Grinda T, Antoine A, Jacot W, Cottu PH, de la Motte Rouge T, Frenel JS, Mailliez A, Dalenc F, Goncalves A, Clatot F, Mouret Reynier MA, Levy C, Ferrero JM, Desmoulins I, Uwer L, Petit T, Jouannaud C, Arnedos M, Chevrot M, Courtinard C, Tredan O, Brain E, — View Citation

Grinda T, Joyon N, Lusque A, Lefevre S, Arnould L, Penault-Llorca F, Macgrogan G, Treilleux I, Vincent-Salomon A, Haudebourg J, Maran-Gonzalez A, Charafe-Jauffret E, Courtinard C, Franchet C, Verriele V, Brain E, Tas P, Blanc-Fournier C, Leroux A, Loussou — View Citation

Heudel P, Delaloge S, Parent D, Madranges N, Levy C, Dalenc F, Brain E, Uwer L, D'Hondt V, Augereau P, Mailliez A, Perrin C, Frenel JS, Sablin MP, Mouret-Reynier MA, Vermeulin T, Eymard JC, Petit T, Ferrero JM, Ilie S, Goncalves A, Chenuc G, Robain M, Sim — View Citation

Hotton J, Lusque A, Leufflen L, Campone M, Levy C, Honart JF, Mailliez A, Debled M, Gutowski M, Leheurteur M, Goncalves A, Jankowski C, Guillermet S, Bachelot T, Ferrero JM, Eymard JC, Petit T, Pouget N, de La Lande B, Frenel JS, Villacroux O, Simon G, Po — View Citation

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. Re — View Citation

Jacot W, Lusque A, Vicier C, Mailliez A, de La Motte Rouge T, Cabel L, Levy C, Patsouris A, Desmoulins I, Uwer L, Thery JC, Robain M, Caron O, Tredan O, Filleron T, Frenel JS, Delaloge S. Outcomes of patients with HER2-negative metastatic breast cancer af — View Citation

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. — View Citation

Le Du F, Carton M, Bachelot T, Saghatchian M, Pistilli B, Brain E, Loirat D, Vanlemmens L, Vermeulin T, Emile G, Goncalves A, Ung M, Robert M, Jaffre A, Desmoulins I, Jouannaud C, Uwer L, Marc Ferrero J, Mouret-Reynier MA, Jacot W, Chevrot M, Delaloge S, — View Citation

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, — View Citation

Mailliez A, D'Hondt V, Lusque A, Caron O, Cabel L, Goncalves A, Debled M, Gladieff L, Ferrero JM, Petit T, Mouret-Reynier MA, Eymard JC, Levy C, Uwer L, Leheurteur M, Desmoulins I, Bachelot T, Frenel JS, de la Motte Rouge T, Simon G, Jacot W, Delaloge S. — View Citation

Mallet A, Lusque A, Levy C, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Goncalves A, Desmoulins I, De La Motte Rouge T, Faure C, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Cottu P, Dalenc F, Petit T, Payen O, Uwer L, Guiu S, Frenel JS — View Citation

Moinard-Butot F, Saint-Martin C, Pflumio C, Carton M, Jacot W, Cottu PH, Dieras V, Dalenc F, Goncalves A, Debled M, Patsouris A, Mouret-Reynier MA, Vanlemmens L, Leheurteur M, Emile G, Ferrero JM, Desmoulins I, Uwer L, Eymard JC, Cheaib B, Courtinard C, B — View Citation

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, Diera — View Citation

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, Vel — View Citation

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. — View Citation

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. 20 — View Citation

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, Mou — View Citation

Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, 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, Mour — View Citation

Saleh K, Carton M, Dieras V, Heudel PE, Brain E, D'Hondt V, Mailliez A, Patsouris A, Mouret-Reynier MA, Goncalves A, Ferrero JM, Petit T, Emile G, Uwer L, Debled M, Dalenc F, Jouannaud C, Ladoire S, Leheurteur M, Cottu P, Veron L, Savignoni A, Courtinard — View Citation

Sirieix J, Fraisse J, Mathoulin-Pelissier S, Leheurteur M, Vanlemmens L, Jouannaud C, Dieras V, Levy C, Ung M, Mouret-Reynier MA, Petit T, Coudert B, Brain E, Pistilli B, Ferrero JM, Goncalves A, Uwer L, Patsouris A, Tredan O, Courtinard C, Gourgou S, Fre — View Citation

Vasseur A, Carton M, Guiu S, Augereau P, Uwer L, Mouret-Reynier MA, Levy C, Eymard JC, Ferrero JM, Leheurteur M, Goncalves A, Robert M, De La Motte Rouge T, Bachelot T, Petit T, Debled M, Grinda T, Desmoulins I, Vanlemmens L, Nicolai V, Simon G, Cabel L. — View Citation

* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the evolution of therapeutic care	Patient characteristics, tumor characteristics and treatment patterns	baseline
Secondary	Describe the impact of therapeutic strategies on survival criteria	Overall survival	From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2023.
Secondary	Describe the impact of therapeutic strategies on survival criteria	Progression free survival	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.