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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Etienne Brain

Affiliation: Institut Curie, Saint Cloud

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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