240
Participants
Start Date
December 5, 2024
Primary Completion Date
September 30, 2027
Study Completion Date
April 30, 2028
Everolimus
Patients will receive 7.5 mg of everolimus orally once daily.
Elacestrant
Patients will receive elacestrant 345 mg orally once daily
Placebo
Patients will receive placebo orally once daily
Auxiliary Medicinal Product - Dexamethasone
10 mL of alcohol-free dexamethasone 0.5 mg per 5 mL mouthwashes (swish for 2 min and spit, four times daily for 8 weeks). After 8 weeks, dexamethasone mouthwash could be continued for up to eight additional weeks at the discretion of the clinician and patient. Used for prevention of treatment-induced stomatitis.
Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues
According to clinical practice (for premenopausal/perimenopausal patients and male patients in both treatment arms). Used to suppress estrogen production.
RECRUITING
Medizinische Universität Innsbruck, Innsbruck
RECRUITING
Ordensklinikum Linz Barmherzige Schwestern, Linz
RECRUITING
Ordination Priv.-Doz. Dr. Michael Hubalek, Schwaz
RECRUITING
Masaryk Memorial Cancer Institute, Brno
RECRUITING
Multiscan Nemocnice Horovice, Hořovice
RECRUITING
Polyclinique Bordeaux Nord Aquitaine, Bordeau
RECRUITING
Centre Georges François Leclerc, Dijon
RECRUITING
CHU Lyon Sud, Lyon
RECRUITING
Hospital prive des Cotes d'Amor, Plérin
RECRUITING
CHU Saint Etienne, Saint-Priest-en-Jarez
RECRUITING
IUCT Oncopole, Toulouse
RECRUITING
Institute de Cancerologie de Lorraine - Nancy, Vandœuvre-lès-Nancy
RECRUITING
MVZ II der Niels Stensen Kliniken, Georgsmarienhütte
RECRUITING
Klinikum Worms - Frauenklinik, Worms
RECRUITING
University General Hospital Alexandroupoli, Alexandroupoli
RECRUITING
251 Air Force General Hospital, Athens
RECRUITING
Aretaeio Hospital, Athens
RECRUITING
Attikon University Hospital, Athens
RECRUITING
Metropolitan General Hospital 4th department, Athens
RECRUITING
University General Hospital of Heraklion, Heraklion
RECRUITING
University General Hospital of Larissa, Larissa
RECRUITING
Metropolitan Hospital Greece 1st department, Piraeus
RECRUITING
EU Interbalkan Medical Center, Thessaloniki
RECRUITING
Ospedali Riuniti Livorno, Livorno
RECRUITING
Instituto Europeo di Oncologia, Milan
RECRUITING
Azienda Ospedaliero- Universitaria Maggiore Della Carita, Novara
RECRUITING
Centro Oncológico de Galicia, A Coruña
RECRUITING
Complejo Hospitalario Universitario de Santiago (CHUS), A Coruña
RECRUITING
Hospital General Universitario Dr. Balmis (Alicante), Alicante
RECRUITING
Hospital Universitario San Juan de Alicante, Alicante
RECRUITING
Institut Català d' Oncologia Badalona (ICO), Badalona
RECRUITING
Hospital Clínic i Provincial de Barcelona, Barcelona
RECRUITING
Hospital del Mar, Barcelona
RECRUITING
Hospital Universitari Dexeus, Barcelona
RECRUITING
Hospital Universitari Vall D'Hebron, Barcelona
RECRUITING
Hospital Universitario de Basurto, Bilbao
RECRUITING
Hospital Universitario de Burgos, Burgos
RECRUITING
Hospital Provincial de Castellón, Castellon
RECRUITING
Hospital San Pedro de Alcántara, Cáceres
RECRUITING
Hospital Universitario Clínico San Cecilio de Granada, Granada
RECRUITING
Complejo Hospitalario de Jaén, Jaén
RECRUITING
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria
RECRUITING
Hospital Universitario de León, León
RECRUITING
Hospital Universitario Arnau de Vilanova de Lleida, Lleida
RECRUITING
Hospital Beata María Ana, Madrid
RECRUITING
Hospital Universitario Doce de Octubre, Madrid
RECRUITING
Hospital Universitario La Paz, Madrid
RECRUITING
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
RECRUITING
Hospital Universitario Ramón y Cajal, Madrid
RECRUITING
Hospital Universitario Sanchinarro-START-CIOCC, Madrid
RECRUITING
MD Anderson Cancer Center Madrid, Madrid
RECRUITING
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia
RECRUITING
Hospital Universitari Son Espases, Palma de Mallorca
RECRUITING
Hospitalario Universitario de Navarra, Pamplona
RECRUITING
Hospital Universitario de Canarias, Santa Cruz de Tenerife
RECRUITING
Hospital Quirónsalud Sagrado Corazón, Seville
RECRUITING
Hospital Universitario Virgen del Rocío, Seville
RECRUITING
Hospital Universitario Virgen Macarena, Seville
RECRUITING
Hospital Universitari Sant Joan de Reus, Tarragona
RECRUITING
Hospital Universitario Marqués de Valdecilla, Valdecilla
RECRUITING
Consorci Hospital General Universitari de València, Valencia
RECRUITING
Hospital Arnau de Vilanova de Valencia, Valencia
RECRUITING
Hospital Clínico Universitario de Valencia, Valencia
RECRUITING
Hospital Universitario La Ribera - Alzira, Valencia
RECRUITING
Hospital Clínico Universitario Lozano Blesa, Zaragoza
RECRUITING
Barts Health NHS Trust, London
RECRUITING
Royal Cornwall Hospital NHS Trust, Truro
RECRUITING
Genesis Cancer Care UK, Waterlooville
Stemline Therapeutics, Inc.
INDUSTRY
MedSIR
OTHER