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
3 other identifiers
interventional
1,989
2 countries
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Apr 2012
Longer than P75 for phase_3 breast-cancer
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedStudy Start
First participant enrolled
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJune 26, 2025
June 1, 2025
10 years
March 23, 2012
June 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
The OS is defined as the interval between the date of randomization and the date of death from any cause.
Median follow-up = 4 years
Secondary Outcomes (10)
Specific overall survival
median follow-up = 4 years
Disease-free survival (DFS)
median follow-up = 4 years
Event-free survival (ESF)
median follow-up = 4 years
Acute and late toxicity during the study
Throughout treatment completion, up to 4 years
Geriatric Assessment
at the end of the chemotherapy in arm B or 16 weeks after the randomization in arm A (endocrine treatment only), and then each year during a 4-year follow-up period, for both arms
- +5 more secondary outcomes
Study Arms (2)
Arm A: ENDOCRINE TREATMENT
OTHERHORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).
Arm B: CHEMOTHERAPY + ENDOCRINE TREATMENT
EXPERIMENTALHORMONOTHERAPY (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)
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (84)
Clinique du Sud Luxembourg
Arlon, Belgium
Cliniques universitaires Saint-Luc - UCL
Brussels, 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
Liège, 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, France
Centre Hospitalier René Dubos
Cergy-Pontoise, France
CH de Cholet
Cholet, France
Hôpital Antoine Béclère
Clamart, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130, France
Groupement Hospitalier Public du Sud de l'Oise - site de Creil
Creil, France
CHI de Créteil
Créteil, 94010, France
Hôpital Henri Mondor
Créteil, 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
Épinal, France
Clinique Sainte Marguerite
Hyères, France
CHD de Vendée
La Roche-sur-Yon, 85000, France
CH de Lagny sur Marne
Lagny-sur-Marne, France
CH du Mans
Le Mans, 72000, France
Clinique Victor Hugo
Le Mans, France
Clinique Hartmann
Levallois-Perret, France
Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, 87042, France
Centre Hospitalier de Bretagne Sud
Lorient, France
Centre Léon Bérard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
CH de Mâcon - Les Chanaux
Mâcon, France
Centre Hospitalier Intercommunal de Meulan - Les Mureaux
Meulan-en-Yvelines, France
CH Layné
Mont-de-Marsan, France
Clinique du Pont de Chaume
Montauban, 82017, France
Centre Val d'Aurelle - Paul Lamarque
Montpellier, France
Centre Antoine Lacassagne
Nice, France
CHR d'Orléans
Orléans, 45100, France
Groupe Hospitalier Paris St Joseph
Paris, 75014, France
Groupe Hospitalier des Diaconesses - Croix Saint Simon
Paris, France
Institut Curie - Hôpital Claudius Regaud
Paris, France
Polyclinique de Francheville
Périgueux, 24000, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU de Poitiers
Poitiers, 86021, 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
Institut Curie - Hôpital René Huguenin
Saint-Cloud, France
CHI Poissy Saint Germain
Saint-Germain-en-Laye, France
CHP Saint Grégoire
Saint-Grégoire, France
ICO -Centre René Gauducheau
Saint-Herblain, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 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
Vandœuvre-lès-Nancy, France
Centre Saint Yves
Vannes, 56001, France
CH Bretagne Atlantique
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, France
Related Publications (1)
Brain E, Mir O, Bourbouloux E, Rigal O, Ferrero JM, Kirscher S, Allouache D, D'Hondt V, Savoye AM, Durando X, Duhoux FP, Venat-Bouvet L, Blot E, Canon JL, Rollot-Trad F, Bonnefoi H, Roque T, Lemonnier J, Latouche A, Henriques J, Lacroix-Triki M, Vernerey D; GERICO&UCBG/Unicancer. Adjuvant chemotherapy and hormonotherapy versus adjuvant hormonotherapy alone for women aged 70 years and older with high-risk breast cancer based on the genomic grade index (ASTER 70s): a randomised phase 3 trial. Lancet. 2025 Aug 2;406(10502):489-500. doi: 10.1016/S0140-6736(25)00832-3.
PMID: 40752909DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etienne Brain
Institut Curie, Saint Cloud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 27, 2012
Study Start
April 12, 2012
Primary Completion
April 11, 2022
Study Completion
March 1, 2026
Last Updated
June 26, 2025
Record last verified: 2025-06