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NOT YET RECRUITING
NCT07661927
PHASE2

Skipping Hormone Therapy in Low-Risk Early Breast Cancer

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

Interventions

DRUG

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