AzTrials
AzTrials

Breast CancerPhase 3ASTER 70sNCT01564056

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

A Phase 3 study testing HORMONOTHERAPY and CHEMOTHERAPY then HORMONOTHERAPY in people with Breast Cancer, run by UNICANCER at 84 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
HORMONOTHERAPY and CHEMOTHERAPY then HORMONOTHERAPY
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,989 participants
Where
84 sitesin 2 countries
Study dates
12 Apr 2012to Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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),
Show all 14Show fewer
  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

84 sites in 2 countries.

84 sites in 2 countries

France72 sites

  • Clinique Claude Bernard

    Albi

  • Centre Paul Papin

    Angers

  • CH d'Ardèche méridionale

    Aubenas

  • Institut Sainte Catherine

    Avignon

  • Polyclinique Urbain V

    Avignon

  • Hôpital Avicenne

    Bobigny

  • Institut Bergonié

    Bordeaux

  • CHU de Brest

    Brest

  • Centre François Baclesse

    Caen

  • Centre Hospitalier René Dubos

    Cergy-Pontoise

  • CH de Cholet

    Cholet

  • Hôpital Antoine Béclère

    Clamart

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

  • Groupement Hospitalier Public du Sud de l'Oise - site de Creil

    Creil

  • CHI de Créteil

    Créteil, 94010

  • Hôpital Henri Mondor

    Créteil

  • CH de Dax

    Dax

  • Centre d'oncologie et de radiothérapie du Parc

    Dijon

  • Centre Georges-François Leclerc

    Dijon

  • CH Jean Monnet

    Épinal

  • Clinique Sainte Marguerite

    Hyères

  • CHD de Vendée

    La Roche-sur-Yon, 85000

  • CH de Lagny sur Marne

    Lagny-sur-Marne

  • CH du Mans

    Le Mans, 72000

  • Clinique Victor Hugo

    Le Mans

  • Clinique Hartmann

    Levallois-Perret

  • Centre Oscar Lambret

    Lille

  • CHU de Limoges

    Limoges, 87042

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Centre Léon Bérard

    Lyon

  • CH de Mâcon - Les Chanaux

    Mâcon

  • Institut Paoli-Calmettes

    Marseille

  • Centre Hospitalier Intercommunal de Meulan - Les Mureaux

    Meulan-en-Yvelines

  • CH Layné

    Mont-de-Marsan

  • Clinique du Pont de Chaume

    Montauban, 82017

  • Centre Val d'Aurelle - Paul Lamarque

    Montpellier

  • Centre Antoine Lacassagne

    Nice

  • CHR d'Orléans

    Orléans, 45100

  • Groupe Hospitalier Paris St Joseph

    Paris, 75014

  • Groupe Hospitalier des Diaconesses - Croix Saint Simon

    Paris

  • Institut Curie - Hôpital Claudius Regaud

    Paris

  • Polyclinique de Francheville

    Périgueux, 24000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • CHU de Poitiers

    Poitiers, 86021

  • CH de la Région d'Annecy

    Pringy

  • Institut du Cancer Courlancy

    Reims

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes

  • CH de Rodez

    Rodez

  • Centre Henri Becquerel

    Rouen

  • Clinique Mathilde

    Rouen

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud

  • CHI Poissy Saint Germain

    Saint-Germain-en-Laye

  • CHP Saint Grégoire

    Saint-Grégoire

  • ICO -Centre René Gauducheau

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)

    Sarcelles

  • CH de Senlis

    Senlis

  • Centre Paul Strauss

    Strasbourg

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Strasbourg Oncologie Libérale

    Strasbourg

  • Hopitaux du Léman

    Thonon-les-Bains

  • CHI de Toulon - Hopital Sainte Musse

    Toulon

  • Clinique Pasteur

    Toulouse

  • Clinique Saint Jean du Languedoc

    Toulouse

  • Institut Claudius Regaud

    Toulouse

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy

  • Centre Saint Yves

    Vannes, 56001

  • CH Bretagne Atlantique

    Vannes, 56017

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Belgium12 sites

  • Clinique du Sud Luxembourg

    Arlon

  • Cliniques universitaires Saint-Luc - UCL

    Brussels

  • Grand Hopital de Charleroi (GHdC)

    Charleroi

  • Hôpital INDC entité Jolimontoise

    Haine-Saint-Paul

  • Centre Hospitalier de l'Ardenne

    Libramont

  • CHC - Les Cliniques Saint-Joseph

    Liège

  • CHU Ambroise Paré

    Mons

  • Clinique et Maternité Sainte-Elisabeth

    Namur

  • Cliniques Saint-Pierre Ottignies

    Ottignies

  • Centre Hôspitalier de Wallonie Picarde (CHWAPI)

    Tournai

  • CHPLT Verviers

    Verviers

  • CHU Mont-Godinne

    Yvoir

Other trials in Belgium

About this study

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

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.

Read the 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
  1. 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.
  1. 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.
Conditions
Breast Cancer
Being tested
HORMONOTHERAPY, CHEMOTHERAPY then HORMONOTHERAPY
Keywords
Adjuvant systemic treatment, Breast cancer, Elderly patients
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HORMONOTHERAPYDrug

    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 then HORMONOTHERAPYDrug

    CHEMOTHERAPY regimen will be chosen amongst the following ones:

    1. 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).

Study groups in NCT01564056
Study groupRoleWhat they receive
Arm A: ENDOCRINE TREATMENTOtherHORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).
Receives: Drug: HORMONOTHERAPY
Arm B: CHEMOTHERAPY + ENDOCRINE TREATMENTExperimentalHORMONOTHERAPY (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)
Receives: Drug: CHEMOTHERAPY then HORMONOTHERAPY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    The OS is defined as the interval between the date of randomization and the date of death from any cause.

    Measured: Median follow-up = 4 years

Secondary outcomes (10)

  1. Specific overall survival

    The specific OS is defined as the interval between the date of randomization and the date of death due to cancer. Alive patients or dead patients from another cause will be censored at the last follow-up

    Measured: median follow-up = 4 years

  2. Disease-free survival (DFS)

    The DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first.

    Measured: median follow-up = 4 years

  3. Event-free survival (ESF)

    The EFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.

    Measured: median follow-up = 4 years

  4. Acute and late toxicity during the study

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout treatment completion, up to 4 years

  5. Geriatric Assessment

    the geriatric questionnaires (CCI \& listing comedications, G8, IADL or MMSE) will be completed by a geriatrician or a person trained to geriatric assessment before randomization, 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.

    Measured: 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

  6. Four-Year Mortality Index for Older Adults(Lee Score)

    A 4-year mortality score including items depicting functional status, nutritional status and comorbidities, three key issues in elderly, will be systematically calculated.

    Measured: At the inclusion

  7. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, week 16, 5 months, 6 months, 1 year, 2 years, 3 years, and 4 years

  8. Quality of life questionnaire - Elderly cancer patients (QLQ-ELD15)

    The EORTC QLQ-ELD15, a validated HRQOL questionnaire for cancer patients aged greater than or equal to 70 years, is intended to supplement the QLQ-C30.

    The QLQ-ELD15 contains 15 items incorporating five scales to assess mobility, family support, worries about future, autonomy and maintaining purpose, and burden of illness. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. High scores indicate poor mobility, good family support, less worried about the future, poor autonomy and maintaining purpose, and high burden of illness.

    Measured: At baseline, week 16, 5 months, 6 months, 1 year, 2 years, 3 years, and 4 years

  9. Usefulness of GG by RT-PCR

    The prognostic signature of the GG test will be evaluated in an elderly population by comparison to standardized routine histopathological criteria and to the results obtained in the general non elderly population. In the whole cohort (n=2000) results of the GG will be compared to routine histopathological characteristics (pN, histological grade, mitotic count, Ki67 index, determination of Elston and Ellis histological grade) as determined locally or centrally for assessment of patient prognosis.

    Measured: two weeks after surgery (local histo. and GG test) then after inclusions are performed (central histo.)

  10. Cost-effectiveness analysis

    In parallel with efficacy analysis, measured by an objective clinical result indicator of state of health, such as the number of year gained (overall survival), costs for the two treatment strategies (endocrine treatment only or endocrine treatment and chemotherapy) in adjuvant systematic treatment will be also estimated. This study should provide information for decision-makers about the incremental efficacy obtained in relation to the incremental cost.

    Measured: at the end of the chemotherapy in arm B or 16 weeks after randomization in arm A, and then each year during a 4-year follow-up period, for both arms of the group I.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study start12 Apr 2012
  3. Primary completion11 Apr 2022
  4. Study completionApr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01564056
Sponsor's protocol ID
GERICO11/PACS10
Other IDs
2011-004744-22, UC-0103/1102
Acronym
ASTER 70s
Status last verified
Jul 2026
First submitted
23 Mar 2012
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40752909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HORMONOTHERAPY and CHEMOTHERAPY then HORMONOTHERAPY in people with Breast Cancer, run by UNICANCER at 84 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Median follow-up = 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01564056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in