Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

May 3, 2022

Primary Completion Date

October 1, 2029

Study Completion Date

December 1, 2031

Conditions
Breast Cancer Stage II
Interventions
DRUG

Ribociclib (neoadjuvant)

Ribociclib 600 mg/day + letrozole during neoadjuvant phase.

DRUG

Chemotherapy (adjuvant)

Adjuvant chemotherapy. 3 regimens are permitted.

DRUG

Ribociclib (adjuvant)

Ribociclib 400 mg/day + letrozole (or other aromatase inhibitor) during adjuvant phase.

Trial Locations (51)

Unknown

RECRUITING

Sainte Catherine - Institut du Cancer Avignon Provence, Avignon

RECRUITING

Centre Hospitalier de la Côte Basque, Bayonne

RECRUITING

Centre Hospitalier Universitaire de Besancon, Besançon

RECRUITING

Hôpital Simone veil de Blois, Blois

RECRUITING

Centre François Baclesse, Caen

RECRUITING

Centre Hospitalier de Cholet, Cholet

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble

RECRUITING

Hôpital Franco Britanique Fondation Cognacq Jay, Levallois-Perret

RECRUITING

Centre Oscar lambret, Lille

RECRUITING

Centre Hospitalier Universitaire de Limoges, Limoges

RECRUITING

Centre Léon Berard, Lyon

RECRUITING

Hôpital privé Jean Mermoz, Lyon

RECRUITING

Institut Paoli Calmettes, Marseille

RECRUITING

Hôpital privé de Confluent, Nantes

RECRUITING

Institut Curie, Paris

RECRUITING

Centre Hospitalier Universitaire de Poitiers, Poitiers

RECRUITING

Centre Hospitalier les Cornouaille, Quimper

RECRUITING

Institut Jean Godinot, Reims

RECRUITING

Centre Eugène Marquis, Rennes

RECRUITING

Institut Curie, Saint-Cloud

RECRUITING

Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire

RECRUITING

Clinique Mutualiste de l'Estuaire - Groupe HGO, Saint-Nazaire

RECRUITING

Clinique Sainte Anne - Strasbourg Oncologie Libérale, Strasbourg

RECRUITING

Institut de cancérologie Strasbourg Europe - ICANS, Strasbourg

RECRUITING

Hopitaux du Léman, Thonon-les-Bains

RECRUITING

Clinique Pasteur, Toulouse

RECRUITING

Institut Claudius Regaud, IUCT-Oncopole, Toulouse

RECRUITING

Nouvelle Clinique des Dentellières, Valenciennes

RECRUITING

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

RECRUITING

Centre Hospitalier Bretagne Atlantique, Vannes

RECRUITING

Gustave Roussy, Villejuif

SUSPENDED

Hospital da Luz, Lisbon

SUSPENDED

Hospital de São Francisco Xavier, Lisbon

SUSPENDED

IPO Porto, Porto

RECRUITING

Hospital Son Espases, Palma de Mallorca

RECRUITING

ICO Badalona, Badalona

RECRUITING

ICO Hospitalet, L'Hospitalet de Llobregat

RECRUITING

Hospital Clinic de Barcelona, Barcelona

RECRUITING

Hospital Vall d'Hebron, Barcelona

RECRUITING

Hospital Universiatrio Clínico San Cecilio, Granada

RECRUITING

Complejo Asistencial Universitario de León, León

RECRUITING

Fundación Jiménez Díaz, Madrid

RECRUITING

HM Sanchinarro, Madrid

RECRUITING

Hospital 12 de Octubre, Madrid

RECRUITING

Hospital Ramón y Cajal, Madrid

RECRUITING

Complejo Asistencial Universitario de Salamanca, Salamanca

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

RECRUITING

Hospital Clínico de Valencia, Valencia

RECRUITING

Instituto Valenciano de Oncología, Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

UNICANCER

OTHER

lead

SOLTI Breast Cancer Research Group

OTHER

NCT05296746 - Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer | Biotech Hunter | Biotech Hunter