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Could adding chemo help older breast cancer patients live longer? a major trial investigates.

NCT ID NCT01564056

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This phase 3 trial compares two treatment approaches for women aged 70 and older with estrogen-receptor-positive, HER2-negative breast cancer. Participants receive either hormone therapy alone for five years or chemotherapy followed by hormone therapy. The study aims to see if adding chemotherapy improves overall survival, especially in those with a high genomic grade indicating greater risk of relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (docetaxel, cyclophosphamide, or doxorubicin) plus hormone therapy (tamoxifen or aromatase inhibitor)
What this could lead to
If successful, this could show that adding chemotherapy to hormone therapy helps older women with high-risk breast cancer live longer.
What could go wrong
This is a large trial, but the benefit of chemotherapy in older adults is uncertain and may come with significant side effects. The results may not apply to all older patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,989 people

The number who actually took part.

Started

Apr 2012

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • CH Bretagne Atlantique

    Vannes, 56017, France

  • CH Jean Monnet

    Épinal, France

  • CH Layné

    Mont-de-Marsan, France

  • CH d'Ardèche méridionale

    Aubenas, France

  • CH de Cholet

    Cholet, France

  • CH de Dax

    Dax, France

  • CH de Lagny sur Marne

    Lagny-sur-Marne, France

  • CH de Mâcon - Les Chanaux

    Mâcon, France

  • CH de Rodez

    Rodez, France

  • CH de Senlis

    Senlis, France

  • CH de la Région d'Annecy

    Pringy, France

  • CH du Mans

    Le Mans, 72000, France

  • CHC - Les Cliniques Saint-Joseph

    Liège, Belgium

  • CHD de Vendée

    La Roche-sur-Yon, 85000, France

  • CHI Poissy Saint Germain

    Saint-Germain-en-Laye, France

  • CHI de Créteil

    Créteil, 94010, France

  • CHI de Toulon - Hopital Sainte Musse

    Toulon, France

  • CHP Saint Grégoire

    Saint-Grégoire, France

  • CHPLT Verviers

    Verviers, Belgium

  • CHR d'Orléans

    Orléans, 45100, France

  • CHU Ambroise Paré

    Mons, Belgium

  • CHU Mont-Godinne

    Yvoir, Belgium

  • CHU de Brest

    Brest, France

  • CHU de Limoges

    Limoges, 87042, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre François Baclesse

    Caen, France

  • Centre Georges-François Leclerc

    Dijon, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130, France

  • Centre Hospitalier Intercommunal de Meulan - Les Mureaux

    Meulan-en-Yvelines, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, France

  • Centre Hospitalier de Bretagne Sud

    Lorient, France

  • Centre Hospitalier de l'Ardenne

    Libramont, Belgium

  • Centre Hôspitalier de Wallonie Picarde (CHWAPI)

    Tournai, Belgium

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, France

  • Centre Oscar Lambret

    Lille, France

  • Centre Paul Papin

    Angers, France

  • Centre Paul Strauss

    Strasbourg, France

  • Centre Saint Yves

    Vannes, 56001, France

  • Centre Val d'Aurelle - Paul Lamarque

    Montpellier, France

  • Centre d'oncologie et de radiothérapie du Parc

    Dijon, France

  • Clinique Claude Bernard

    Albi, France

  • Clinique Hartmann

    Levallois-Perret, France

  • Clinique Mathilde

    Rouen, France

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique Saint Jean du Languedoc

    Toulouse, France

  • Clinique Sainte Marguerite

    Hyères, France

  • Clinique Victor Hugo

    Le Mans, France

  • Clinique du Pont de Chaume

    Montauban, 82017, France

  • Clinique du Sud Luxembourg

    Arlon, Belgium

  • Clinique et Maternité Sainte-Elisabeth

    Namur, Belgium

  • Cliniques Saint-Pierre Ottignies

    Ottignies, Belgium

  • Cliniques universitaires Saint-Luc - UCL

    Brussels, Belgium

  • Grand Hopital de Charleroi (GHdC)

    Charleroi, Belgium

  • Groupe Hospitalier Paris St Joseph

    Paris, 75014, France

  • Groupe Hospitalier des Diaconesses - Croix Saint Simon

    Paris, France

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

    Creil, France

  • Hopitaux du Léman

    Thonon-les-Bains, France

  • Hôpital Antoine Béclère

    Clamart, France

  • Hôpital Avicenne

    Bobigny, France

  • Hôpital Henri Mondor

    Créteil, France

  • Hôpital INDC entité Jolimontoise

    Haine-Saint-Paul, Belgium

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

  • ICO -Centre René Gauducheau

    Saint-Herblain, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie - Hôpital Claudius Regaud

    Paris, France

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, France

  • Institut Gustave Roussy

    Villejuif, France

  • Institut Jean Godinot

    Reims, France

  • Institut Paoli-Calmettes

    Marseille, France

  • Institut Sainte Catherine

    Avignon, France

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, France

  • Institut du Cancer Courlancy

    Reims, France

  • Polyclinique Urbain V

    Avignon, France

  • Polyclinique de Francheville

    Périgueux, 24000, France

  • RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)

    Sarcelles, France

  • Strasbourg Oncologie Libérale

    Strasbourg, France

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