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 (ASTER 70s)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Adjuvant systemic treatment, Breast cancer, Elderly patients
Eligibility Criteria
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Clinique du Sud Luxembourg
- Cliniques universitaires Saint-Luc - UCL
- Grand Hopital de Charleroi (GHdC)
- Hôpital INDC entité Jolimontoise
- Centre Hospitalier de l'Ardenne
- CHC - Les Cliniques Saint-Joseph
- CHU Ambroise Paré
- Clinique et Maternité Sainte-Elisabeth
- Cliniques Saint-Pierre Ottignies
- Centre Hôspitalier de Wallonie Picarde (CHWAPI)
- CHPLT Verviers
- CHU Mont-Godinne
- Clinique Claude Bernard
- Centre Paul Papin
- CH d'Ardèche méridionale
- Institut Sainte Catherine
- Polyclinique Urbain V
- Hôpital Avicenne
- Institut Bergonié
- CHU de Brest
- Centre François Baclesse
- Centre Hospitalier René Dubos
- CH de Cholet
- Hôpital Antoine Béclère
- Centre Jean Perrin
- Centre Hospitalier Alpes Léman
- Groupement Hospitalier Public du Sud de l'Oise - site de Creil
- CHI de Créteil
- Hôpital Henri Mondor
- CH de Dax
- Centre d'oncologie et de radiothérapie du Parc
- Centre Georges-François Leclerc
- CH Jean Monnet
- Clinique Sainte Marguerite
- CHD de Vendée
- CH de Lagny sur Marne
- CH du Mans
- Clinique Victor Hugo
- Clinique Hartmann
- Centre Oscar Lambret
- CHU de Limoges
- Centre Hospitalier de Bretagne Sud
- Centre Léon Bérard
- Institut Paoli-Calmettes
- Centre Hospitalier Intercommunal de Meulan - Les Mureaux
- CH Layné
- Clinique du Pont de Chaume
- Centre Val d'Aurelle - Paul Lamarque
- CH de Mâcon - Les Chanaux
- Centre Antoine Lacassagne
- CHR d'Orléans
- Groupe Hospitalier Paris St Joseph
- Groupe Hospitalier des Diaconesses - Croix Saint Simon
- Institut Curie - Hôpital Claudius Regaud
- Polyclinique de Francheville
- Centre Hospitalier Lyon Sud
- CHU de Poitiers
- CH de la Région d'Annecy
- Institut du Cancer Courlancy
- Institut Jean Godinot
- Centre Eugène Marquis
- CH de Rodez
- Centre Henri Becquerel
- Clinique Mathilde
- CHI Poissy Saint Germain
- CHP Saint Grégoire
- Institut de Cancérologie de la Loire
- Institut Curie - Hôpital René Huguenin
- ICO -Centre René Gauducheau
- Clinique Mutualiste de l'Estuaire
- RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)
- CH de Senlis
- Centre Paul Strauss
- Hôpitaux Universitaires de Strasbourg
- Strasbourg Oncologie Libérale
- Hopitaux du Léman
- CHI de Toulon - Hopital Sainte Musse
- Clinique Pasteur
- Clinique Saint Jean du Languedoc
- Institut Claudius Regaud
- Centre Alexis Vautrin
- Centre Saint Yves
- CH Bretagne Atlantique
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Arm A: ENDOCRINE TREATMENT
Arm B: CHEMOTHERAPY + ENDOCRINE TREATMENT
HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).
HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II). CHEMOTHERAPY regimen will be chosen amongst the following ones: TC (docetaxel + cyclophosphamide) AC (doxorubicin + cyclophosphamide) MC (liposomal non pegylated doxorubicin [Myocet®]+ cyclophosphamide)