Spots Global Cancer Trial Database for PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
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Trial Identification
Brief Title: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Official Title: Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients
Study ID: NCT03079011
Conditions
Study Description
Brief Summary: This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre Hospitalier Universitaire, Amiens, , France
Clinique de l'Europe, Amiens, , France
Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers, , France
Centre Hospitalier d'Auxerre, Auxerre, , France
Institut Sainte Catherine, Avignon, , France
Centre Hospitalier de Beauvais, Beauvais, , France
Centre Hospitalier de Blois, Blois, , France
Clinique Tivoli Ducos, Bordeaux, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Centre Hospitalier de boulogne sur Mer, Boulogne Sur Mer, , France
Centre Hospitalier Fleyriat, Bourg En Bresse, , France
CHRU Morvan, Brest, , France
Clinique PASTEUR-CFRO, Brest, , France
Centre Francois Baclesse, Caen, , France
Centre Hospitalier René Dubos, Cergy - Pontoise, , France
Medipole de Savoie, Challes Les Eaux, , France
Centre Hôpital Sainte Marie, Chalon-sur-saone, , France
CH William Morey, Chalon-sur-saone, , France
Centre Hospitalier Métropole de Savoie, Chambery, , France
Centre Hospitalier de Cholet, Cholet, , France
Centre Jean Perrin, Clermont-ferrand, , France
Pôle Santé République, Clermont-ferrand, , France
Centre Georges François Leclerc, Dijon, , France
CHI Fréjus St-Raphaël, Frejus, , France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble, Grenoble, , France
Centre Hospitalier Départemental de Vendée, La Roche Sur Yon, , France
Clinique du Cap d'Or, La Seyne-sur-Mer, , France
Centre Hospitalier de Versailles, Le Chesnay, , France
Centre Hospitalier le Mans, Le Mans, , France
Institut Hospitalier Franco-Britannique, Levallois-perret, , France
CHU Dupuytren, Limoges, , France
Clinique François Chénieux, Limoges, , France
Centre Hospitalier Bretagne Sud, Lorient, , France
Centre Leon Berard, Lyon, , France
Clinique de la Sauvegarde, Lyon, , France
Hôpital privé Jean Mermoz, Lyon, , France
Centre d'Oncologie radiothérapie de Macon, Macon, , France
Hôpital Européen Marseille, Marseille, , France
Hôpital Saint Joseph, Marseille, , France
Institut Paoli Calmettes, Marseille, , France
Centre Hospitalier ANNECY GENEVOIS, Metz-Tessy, , France
Clinique Claude Bernard, Metz, , France
CH Mont de Marsan, Mont de Marsan, , France
Centre Hospitalier Montceau les mines, Montceau-les-mines, , France
ICM - Val d'Aurelle, Montpellier, , France
Centre d'Oncologie de Gentilly, Nancy, , France
Hopital Privé du Confluent, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
Centre ONCOGARD - Institut de Cancérologie du Gard, Nimes, , France
Institut Curie, Paris, , France
Hopital Diaconesses-Croix Saint Simon, Paris, , France
Hopital Européen Georges Pompidou, Paris, , France
Saint Louis Hospital, Paris, , France
Centre Hospitalier de Pau, PAU, , France
Polyclinique Francheville, Perigueux, , France
Centre Catalan d'Oncologie, Perpignan, , France
Centre Hospitalier Lyon Sud, Pierre-benite, , France
CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi, Plerin, , France
Centre Hospitalier de Cornouaille, Quimper, , France
Clinique de la Croix du Sud, Quint Fonsegrives, , France
Centre Eugène Marquis, Rennes, , France
Centre de radiothérapie et d'oncologie médicale LE-CROME, Ris Orangis, , France
Centre Henri Becquerel, Rouen, , France
CHP Saint Grégoire, Saint Gregoire, , France
Institut de cancérologie lucien Neuwith, Saint Priest En Jarez, , France
Centre Hospitalier Saint-Brieuc, Saint-Brieuc, , France
Institut Curie - Hôpital René Huguenin, Saint-cloud, , France
Institut de Cancérologie de l'Ouest - Site René Gauducheau, Saint-herblain, , France
Centre Hospitalier de Broussais, Saint-malo, , France
Clinique Mutualiste de l'Estuaire, Saint-nazaire, , France
Centre Paul Stauss, Strasbourg, , France
Clinique de l'Orangerie, Strasbourg, , France
Clinique Sainte Anne, Strasbourg, , France
Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
Hôpitaux du Léman, Thonon-les-Bains, , France
Clinique Pasteur, Toulouse, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier de Tours - Hopital Bretonneau, Tours, , France
Centre Hospitalier Bretagne Atlantique, Vannes, , France
UNEOS Site Hôpital Robert Schuman, Vantoux, , France
Gustave Roussy, Villejuif, , France
Contact Details
Name: François-Clément BIDARD, MD PhD
Affiliation: Institut Curie
Role: PRINCIPAL_INVESTIGATOR
Name: Suzette DELALOGE, MD PhD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
Name: Anne-Claire HARDY BESSARD, MD
Affiliation: Centre Armoricain d'Oncologie
Role: PRINCIPAL_INVESTIGATOR
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