Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT01564056 Active, sans recrutement

Titre

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 (ASTER 70s)

Type

Interventional

Pathologie

Tumeurs du sein

Phase

Phase 3

Promoteur

UNICANCER (Voir sur ClinicalTrials)

Date de début

avril 2012

Date de fin

mars 2026

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Jean Bernard AULIAC	En recrutement IDF	13/05/2024 15:13:45	Contacter
CLCC INSTITUT CURIE		Active, sans recrutement	04/09/2024 13:49:53	Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY	Olivier MIR	Active, sans recrutement	16/04/2024 07:02:22	Contact (sur clinicalTrials)
CLCC RENE HUGUENIN INSTITUT CURIE		Active, sans recrutement	04/09/2024 13:49:36	Contact (sur clinicalTrials)
HOPITAL NOVO	NGUEFACK	Active, sans recrutement	04/07/2024 11:04:58	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne				Contact (sur clinicalTrials)
AP-HP - Hôpital Henri Mondor-Albert Chenevier				Contact (sur clinicalTrials)
GRPE HOSP DIACONESSES-CROIX ST-SIMON				Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Alexis Vautrin - Vandoeuvre Les Nancy - France				Contact (sur clinicalTrials)
Centre Antoine Lacassagne - Nice - France				Contact (sur clinicalTrials)
Centre d'oncologie et de radiothérapie du Parc - Dijon - France				Contact (sur clinicalTrials)
Centre Eugène Marquis - Rennes - France				Contact (sur clinicalTrials)
Centre François Baclesse - Caen Cedex 05 - France				Contact (sur clinicalTrials)
Centre Georges-François Leclerc - Dijon - France				Contact (sur clinicalTrials)
Centre Henri Becquerel - Rouen - France				Contact (sur clinicalTrials)
Centre Hospitalier Alpes Léman - 74130 - Contamine Sur Arve - France				Contact (sur clinicalTrials)
Centre Hospitalier de Bretagne Sud - Lorient - France				Contact (sur clinicalTrials)
Centre Hospitalier Intercommunal de Meulan - Les Mureaux - Meulan-en-Yvelines - France				Contact (sur clinicalTrials)
Centre Hospitalier Lyon Sud - 69310 - Pierre Benite - France				Contact (sur clinicalTrials)
Centre Jean Perrin - 63011 - Clermont Ferrand - France				Contact (sur clinicalTrials)
Centre Léon Bérard - Lyon - France				Contact (sur clinicalTrials)
Centre Oscar Lambret - Lille - France				Contact (sur clinicalTrials)
Centre Paul Papin - Angers - France				Contact (sur clinicalTrials)
Centre Paul Strauss - Strasbourg - France				Contact (sur clinicalTrials)
Centre Saint Yves - 56001 - Vannes - France				Contact (sur clinicalTrials)
Centre Val d'Aurelle - Paul Lamarque - Montpellier - France				Contact (sur clinicalTrials)
CH Bretagne Atlantique - 56017 - Vannes - France				Contact (sur clinicalTrials)
CH d'Ardèche méridionale - Aubenas - France				Contact (sur clinicalTrials)
CH de Cholet - Cholet - France				Contact (sur clinicalTrials)
CH de Dax - DAX - France				Contact (sur clinicalTrials)
CH de la Région d'Annecy - Pringy - France				Contact (sur clinicalTrials)
CH de Lagny sur Marne - Lagny Sur Marne - France				Contact (sur clinicalTrials)
CH de Mâcon - Les Chanaux - Mâcon - France				Contact (sur clinicalTrials)
CH de Rodez - Rodez - France				Contact (sur clinicalTrials)
CH de Senlis - Senlis - France				Contact (sur clinicalTrials)
CH du Mans - 72000 - Le Mans - France				Contact (sur clinicalTrials)
CH Jean Monnet - Epinal - France				Contact (sur clinicalTrials)
CH Layné - Mont de Marsan - France				Contact (sur clinicalTrials)
CHD de Vendée - 85000 - La Roche Sur Yon - France				Contact (sur clinicalTrials)
CHI de Toulon - Hopital Sainte Musse - Toulon - France				Contact (sur clinicalTrials)
CHI Poissy Saint Germain - Saint Germain En Laye - France				Contact (sur clinicalTrials)
CHP Saint Grégoire - Saint Gregoire - France				Contact (sur clinicalTrials)
CHR d'Orléans - 45100 - Orleans - France				Contact (sur clinicalTrials)
CHU de Brest - Brest - France				Contact (sur clinicalTrials)
CHU de Limoges - 87042 - Limoges - France				Contact (sur clinicalTrials)
CHU de Poitiers - 86021 - Poitiers - France				Contact (sur clinicalTrials)
Clinique Claude Bernard - Albi - France				Contact (sur clinicalTrials)
Clinique du Pont de Chaume - 82017 - Montauban - France				Contact (sur clinicalTrials)
Clinique Hartmann - Levallois-perret - France				Contact (sur clinicalTrials)
Clinique Mathilde - Rouen - France				Contact (sur clinicalTrials)
Clinique Mutualiste de l'Estuaire - Saint-nazaire - France				Contact (sur clinicalTrials)
Clinique Pasteur - Toulouse - France				Contact (sur clinicalTrials)
Clinique Saint Jean du Languedoc - Toulouse - France				Contact (sur clinicalTrials)
Clinique Sainte Marguerite - Hyeres - France				Contact (sur clinicalTrials)
Clinique Victor Hugo - Le Mans - France				Contact (sur clinicalTrials)
Groupe Hospitalier Paris St Joseph - 75014 - Paris - France				Contact (sur clinicalTrials)
Groupement Hospitalier Public du Sud de l'Oise - site de Creil - Creil - France				Contact (sur clinicalTrials)
Hôpital Antoine Béclère - Clamart - France				Contact (sur clinicalTrials)
Hopitaux du Léman - Thonon-les-bains - France				Contact (sur clinicalTrials)
Hôpitaux Universitaires de Strasbourg - Strasbourg - France				Contact (sur clinicalTrials)
ICO -Centre René Gauducheau - Saint-Herblain - France				Contact (sur clinicalTrials)
Institut Bergonié - Bordeaux - France				Contact (sur clinicalTrials)
Institut Claudius Regaud - Toulouse - France				Contact (sur clinicalTrials)
Institut Curie - Hôpital René Huguenin - Saint-cloud - France				Contact (sur clinicalTrials)
Institut de Cancérologie de la Loire - Saint Priest En Jarez - France				Contact (sur clinicalTrials)
Institut du Cancer Courlancy - Reims - France				Contact (sur clinicalTrials)
Institut Gustave Roussy - Villejuif - France				Contact (sur clinicalTrials)
Institut Jean Godinot - Reims - France				Contact (sur clinicalTrials)
Institut Paoli-Calmettes - Marseille - France				Contact (sur clinicalTrials)
Institut Sainte Catherine - Avignon - France				Contact (sur clinicalTrials)
Polyclinique de Francheville - 24000 - Perigueux - France				Contact (sur clinicalTrials)
Polyclinique Urbain V - Avignon - France				Contact (sur clinicalTrials)
RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles) - Sarcelles - France				Contact (sur clinicalTrials)
Strasbourg Oncologie Libérale - Strasbourg - France				Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Women aged ≥ 70 yo,

- Histologically proven invasive breast cancer (regardless of the type),

- Complete surgery performed before enrolment: radical modified mastectomy or breast
conservative surgery, with either a sentinel lymph node procedure or axillary lymph
node dissection,

- Any N status (pN+ or pN0),

- No clinically or radiologically detectable metastases (M0),

- Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by
immunohistochemistry (IHC),

- HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH
negative),

- Normal haematological function: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3;
haemoglobin > 9 g/dl,

- Normal hepatic function: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN;
alkaline phosphatases ≤ 3 ULN,

- Creatinine clearance (MDRD formula) ≥ 40 mL/min,

- PS (ECOG) ≤ 2,

- Patient able to comply with the protocol,

- Patients must have signed a written informed consent form prior to any study
specific procedures, including the agreement for the use of archived tumoral
material for genomic screening and data collection,

- Patients must be affiliated to a Social Health Insurance.

Critère de non inclusion

- Any metastatic impairment, including homolateral sub-clavicular node involvement,
regardless of its type,

- Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast
cancer),

- ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),

- HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH
positive,

- Any chemotherapy, hormonal therapy or radiotherapy for breast cancer before surgery,

- PS (ECOG) ≥ 3,

- Any specific contra-indication to the study drugs (including but not limited to
hypersensitivity to the study drugs or their components),

- Patient deprived of freedom or under tutelage,

- Patient unable to comply with the required medical follow-up for geographic, social
or psychological reasons.

NCT01564056 - 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 (ASTER 70s)

Informations générales
Etablissements
Critères
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