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Brief Title: 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
Official Title: Adjuvant Systemic Treatment for Oestrogen-receptor (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) Multicentre Phase III Trial
Study ID: NCT01564056
Brief Summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
Detailed Description: The purpose of this trial is to address the question of the added value of adjuvant chemotherapy on survival in 70+ BC patients with ER+ disease, deemed "at risk of relapse" (pN+ or pN0 with a high prognostic classifier, namely GG by RT-PCR) and planned to receive as well adjuvant endocrine treatment. This benefit will be weighed with the competition exerted by comorbidities on mortality. As in many recently developed trials evaluating specific strategies for the elderly (e.g. CALGB 49907 (8); bevacizumab and colorectal cancer in the PRODIGE 20 elderly program supported by the PHRC 2010), the choice of chemotherapy regimen will be left to the investigator between 3 "standard" ones: TC x 4 (no anthracyclines), AC x 4 or MC x 4 (better cardiac tolerance), in order to obtain enrolment of a less highly selected population, more representative of the general population to the difference of the high selection classically observed in standard oncology trials. In parallel, patients not included in the randomized part (whatever reason) and treated with adjuvant endocrine treatment only will be followed up as a separate observational cohort. 1. Screening All women 70+ having undergone surgery for invasive pN0 or pN+, ER+ HER2- BC, will be screened and invited to participate. Pre-selection will be possible pre-operatively. 2. Prognostic signature After having signed a written informed consent, the prognostic signature Genomic Grade (GG) will be assessed by RT-PCR. 3. Randomization (Group I) Only the patients with a Genomic Grade (GG) considered as high will be randomized (1:1): endocrine treatment only (Arm A) versus endocrine treatment + adjuvant chemotherapy (Arm B). Randomization1:1 between arm A and B will be done using minimization stratified according to pN status (pN+ vs pN0), G8 (≤ vs \> 14), and center. Given (i) the high potential of less cardiotoxic regimen including liposomal formulations for anthracyclines or excluding anthracyclines and (ii) the wish to capture the whole population to depict the heterogeneity of ageing from 70, adjuvant chemotherapy (Arm B) will be left to the choice of investigator amongst 3 standard regimen of same duration, 4 cycles given every 3 weeks + primary prophylactic GCSF: * AC = doxorubicin 60 mg/m² + cyclophosphamide 600 mg/m² * TC = docetaxel 75 mg/m² + cyclophosphamide 600 mg/m² * MC = liposomal non pegylated doxorubicin (Myocet) 60 mg/m² + cyclophosphamide 600 mg/m² 4. Patients not randomized (Group II) Patients not randomized for any reason (low GG, randomization refusal or treatment refusal, etc.) will enter a surveillance program and will be able to participate to other specific geriatric studies (GERICO project to evaluate the impact of comprehensive geriatric assessment on quality of life, treatment administered and BC survival after 75 years; EORTC study to validate the scale specifically developed for elderly ELD15). The Group II will present a triple interest and will participate, together with randomized patients, to achieve the following objectives: * validation of the prognostic value of Genomic Grade and performance of the test in the elderly BC population, as compared to standardized routine histopathological parameters, * translational studies to identify molecular signatures, * collection of descriptive data including comorbidities and polymedication. 5. Endocrine treatment and radiotherapy In both Groups (I and II), the endocrine treatment will be left to the choice of the investigator (tamoxifen, aromatase inhibitor or sequential) and radiotherapy will follow standard guidelines.
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Clinique du Sud Luxembourg, Arlon, , Belgium
Cliniques universitaires Saint-Luc - UCL, Bruxelles, , Belgium
Grand Hopital de Charleroi (GHdC), Charleroi, , Belgium
Hôpital INDC entité Jolimontoise, Haine-Saint-Paul, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
CHC - Les Cliniques Saint-Joseph, Liege, , Belgium
CHU Ambroise Paré, Mons, , Belgium
Clinique et Maternité Sainte-Elisabeth, Namur, , Belgium
Cliniques Saint-Pierre Ottignies, Ottignies, , Belgium
Centre Hôspitalier de Wallonie Picarde (CHWAPI), Tournai, , Belgium
CHPLT Verviers, Verviers, , Belgium
CHU Mont-Godinne, Yvoir, , Belgium
Clinique Claude Bernard, Albi, , France
Centre Paul Papin, Angers, , France
CH d'Ardèche méridionale, Aubenas, , France
Institut Sainte Catherine, Avignon, , France
Polyclinique Urbain V, Avignon, , France
Hôpital Avicenne, Bobigny, , France
Institut Bergonié, Bordeaux, , France
CHU de Brest, Brest, , France
Centre François Baclesse, Caen Cedex 05, , France
Centre Hospitalier René Dubos, Cergy -pontoise, , France
CH de Cholet, Cholet, , France
Hôpital Antoine Béclère, Clamart, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre Hospitalier Alpes Léman, Contamine Sur Arve, , France
Groupement Hospitalier Public du Sud de l'Oise - site de Creil, Creil, , France
CHI de Créteil, Creteil, , France
Hôpital Henri Mondor, Creteil, , France
CH de Dax, DAX, , France
Centre d'oncologie et de radiothérapie du Parc, Dijon, , France
Centre Georges-François Leclerc, Dijon, , France
CH Jean Monnet, Epinal, , France
Clinique Sainte Marguerite, Hyeres, , France
CHD de Vendée, La Roche Sur Yon, , France
CH de Lagny sur Marne, Lagny Sur Marne, , France
CH du Mans, Le Mans, , France
Clinique Victor Hugo, Le Mans, , France
Clinique Hartmann, Levallois-perret, , France
Centre Oscar Lambret, Lille, , France
CHU de Limoges, Limoges, , France
Centre Hospitalier de Bretagne Sud, Lorient, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Hospitalier Intercommunal de Meulan - Les Mureaux, Meulan-en-Yvelines, , France
CH Layné, Mont de Marsan, , France
Clinique du Pont de Chaume, Montauban, , France
Centre Val d'Aurelle - Paul Lamarque, Montpellier, , France
CH de Mâcon - Les Chanaux, Mâcon, , France
Centre Antoine Lacassagne, Nice, , France
CHR d'Orléans, Orleans, , France
Groupe Hospitalier Paris St Joseph, Paris, , France
Groupe Hospitalier des Diaconesses - Croix Saint Simon, Paris, , France
Institut Curie - Hôpital Claudius Regaud, Paris, , France
Polyclinique de Francheville, Perigueux, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU de Poitiers, Poitiers, , France
CH de la Région d'Annecy, Pringy, , France
Institut du Cancer Courlancy, Reims, , France
Institut Jean Godinot, Reims, , France
Centre Eugène Marquis, Rennes, , France
CH de Rodez, Rodez, , France
Centre Henri Becquerel, Rouen, , France
Clinique Mathilde, Rouen, , France
CHI Poissy Saint Germain, Saint Germain En Laye, , France
CHP Saint Grégoire, Saint Gregoire, , France
Institut de Cancérologie de la Loire, Saint Priest En Jarez, , France
Institut Curie - Hôpital René Huguenin, Saint-cloud, , France
ICO -Centre René Gauducheau, Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire, Saint-nazaire, , France
RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles), Sarcelles, , France
CH de Senlis, Senlis, , France
Centre Paul Strauss, Strasbourg, , France
Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
Strasbourg Oncologie Libérale, Strasbourg, , France
Hopitaux du Léman, Thonon-les-bains, , France
CHI de Toulon - Hopital Sainte Musse, Toulon, , France
Clinique Pasteur, Toulouse, , France
Clinique Saint Jean du Languedoc, Toulouse, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre Les Nancy, , France
Centre Saint Yves, Vannes, , France
CH Bretagne Atlantique, Vannes, , France
Institut Gustave Roussy, Villejuif, , France
Name: Etienne Brain
Affiliation: Institut Curie, Saint Cloud
Role: PRINCIPAL_INVESTIGATOR