Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,989

Participants

Timeline

Start Date

April 12, 2012

Primary Completion Date

April 11, 2022

Study Completion Date

March 31, 2026

Conditions
Breast Cancer
Interventions
DRUG

HORMONOTHERAPY

"Hormonotherapy will be administered during 5 years following chemotherapy when allocated.~(Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II)."

DRUG

CHEMOTHERAPY then HORMONOTHERAPY

"CHEMOTHERAPY regimen will be chosen amongst the following ones:~i) 4 cycles of TC (docetaxel + cyclophosphamide)~* Docetaxel 75 mg/m² IV infusion at hospital every 21 days~* Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days~ii) 4 cycles of AC (doxorubicin + cyclophosphamide)~* Doxorubicin 60 mg/m² IV infusion at hospital every 21 days~* Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days~iii) 4 cycles of MC (liposomal non pegylated doxorubicin \[Myocet®\]+ cyclophosphamide)~* Myocet® 60 mg/m² IV infusion at hospital every 21 days~* Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days~HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II)."

Trial Locations (84)

24000

Polyclinique de Francheville, Périgueux

45100

CHR d'Orléans, Orléans

56001

Centre Saint Yves, Vannes

56017

CH Bretagne Atlantique, Vannes

63011

Centre Jean Perrin, Clermont-Ferrand

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

72000

CH du Mans, Le Mans

74130

Centre Hospitalier Alpes Léman, Contamine-sur-Arve

75014

Groupe Hospitalier Paris St Joseph, Paris

82017

Clinique du Pont de Chaume, Montauban

85000

CHD de Vendée, La Roche-sur-Yon

86021

CHU de Poitiers, Poitiers

87042

CHU de Limoges, Limoges

94010

CHI de Créteil, Créteil

Unknown

Clinique du Sud Luxembourg, Arlon

Cliniques universitaires Saint-Luc - UCL, Brussels

Grand Hopital de Charleroi (GHdC), Charleroi

Hôpital INDC entité Jolimontoise, Haine-Saint-Paul

Centre Hospitalier de l'Ardenne, Libramont

CHC - Les Cliniques Saint-Joseph, Liège

CHU Ambroise Paré, Mons

Clinique et Maternité Sainte-Elisabeth, Namur

Cliniques Saint-Pierre Ottignies, Ottignies

Centre Hôspitalier de Wallonie Picarde (CHWAPI), Tournai

CHPLT Verviers, Verviers

CHU Mont-Godinne, Yvoir

Clinique Claude Bernard, Albi

Centre Paul Papin, Angers

CH d'Ardèche méridionale, Aubenas

Institut Sainte Catherine, Avignon

Polyclinique Urbain V, Avignon

Hôpital Avicenne, Bobigny

Institut Bergonié, Bordeaux

CHU de Brest, Brest

Centre François Baclesse, Caen

Centre Hospitalier René Dubos, Cergy-Pontoise

CH de Cholet, Cholet

Hôpital Antoine Béclère, Clamart

Groupement Hospitalier Public du Sud de l'Oise - site de Creil, Creil

Hôpital Henri Mondor, Créteil

CH de Dax, Dax

Centre d'oncologie et de radiothérapie du Parc, Dijon

Centre Georges-François Leclerc, Dijon

CH Jean Monnet, Épinal

Clinique Sainte Marguerite, Hyères

CH de Lagny sur Marne, Lagny-sur-Marne

Clinique Victor Hugo, Le Mans

Clinique Hartmann, Levallois-Perret

Centre Oscar Lambret, Lille

Centre Hospitalier de Bretagne Sud, Lorient

Centre Léon Bérard, Lyon

Institut Paoli-Calmettes, Marseille

CH de Mâcon - Les Chanaux, Mâcon

Centre Hospitalier Intercommunal de Meulan - Les Mureaux, Meulan-en-Yvelines

CH Layné, Mont-de-Marsan

Centre Val d'Aurelle - Paul Lamarque, Montpellier

Centre Antoine Lacassagne, Nice

Groupe Hospitalier des Diaconesses - Croix Saint Simon, Paris

Institut Curie - Hôpital Claudius Regaud, Paris

CH de la Région d'Annecy, Pringy

Institut du Cancer Courlancy, Reims

Institut Jean Godinot, Reims

Centre Eugène Marquis, Rennes

CH de Rodez, Rodez

Centre Henri Becquerel, Rouen

Clinique Mathilde, Rouen

Institut Curie - Hôpital René Huguenin, Saint-Cloud

CHI Poissy Saint Germain, Saint-Germain-en-Laye

CHP Saint Grégoire, Saint-Grégoire

ICO -Centre René Gauducheau, Saint-Herblain

Clinique Mutualiste de l'Estuaire, Saint-Nazaire

Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez

RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles), Sarcelles

CH de Senlis, Senlis

Centre Paul Strauss, Strasbourg

Hôpitaux Universitaires de Strasbourg, Strasbourg

Strasbourg Oncologie Libérale, Strasbourg

Hopitaux du Léman, Thonon-les-Bains

CHI de Toulon - Hopital Sainte Musse, Toulon

Clinique Pasteur, Toulouse

Clinique Saint Jean du Languedoc, Toulouse

Institut Claudius Regaud, Toulouse

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

UNICANCER

OTHER

NCT01564056 - Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment | Biotech Hunter | Biotech Hunter