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

NCT ID NCT01564056

Completed Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

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.

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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

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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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