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Skipping Hormone Therapy in Low-Risk Early Breast Cancer
Sponsor: UNICANCER
Summary
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life. All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.
Official title: No Endocrine Therapy in Small HR⁺/HER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial
Key Details
Gender
FEMALE
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-06-15
Completion Date
2033-06-15
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
Removing Endocrine Therapy
The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.
Locations (41)
Ico Angers
Angers, France
Sainte Catherine, Institut du Cancer Avignon-Provence
Avignon, France
CH Aunay-Bayeux
Bayeux, France
CHCB
Bayonne, France
Clinique Tivoli
Bordeaux, France
Institut Bergonié
Bordeaux, France
CH Boulogne sur mer
Boulogne-sur-Mer, France
Clinique Pasteur Lanroze
Brest, France
CH de Bligny
Briis-sous-Forges, France
Centre Francois Baclesse
Caen, France
Pole Sante Leonard de Vinci- Roc37
Chambray-lès-Tours, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Leonard de Vinci
Dechy, France
Centre Georges François Leclerc
Dijon, France
CH Annecy Genevois
Épagny, France
CHD Vendée
La Roche-sur-Yon, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, France
Groupe Hospitalier Bretagne Sud
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital privé Jean Mermoz
Lyon, France
Hôpital Privé Clairval
Marseille, France
Institut Paoli-Calmettes
Marseille, France
CHI de Mont-de-Marsan
Mont-de-Marsan, France
Centre Antoine Lacassagne
Nice, France
CHU Orleans
Orléans, France
CHP Sainte Marie
Osny, France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Institut Curie
Paris, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut Curie
Saint-Cloud, France
Ico Saint Herblain
Saint-Herblain, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
Centre de lutte contre le cancer - Paul Strauss
Strasbourg, France
Hôpitaux du Léman
Thonon-les-Bains, France
IUCT-Oncopole
Toulouse, France
CHU Tours
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Groupe UNEOS-Hôpital Robert Schuman
Vantoux, France