Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent rozumie cel badania i wyraził świadomą zgodę na udział.
- •Pacjent ma ukończone 18 lat.
- •Kobiety w okresie przed- lub okołomenopauzalnym, lub mężczyźni, muszą otrzymywać lek analogiczny do LHRH przez co najmniej 28 dni.
- •Kobiety po menopauzie (np. powyżej 60 lat, lub młodsze z brakiem miesiączki przez rok i potwierdzonymi wynikami badań, lub po usunięciu jajników).
- •Potwierdzony histologicznie lub cytologicznie rak piersi z przerzutami lub nieoperacyjny, nawrotowy, który nie kwalifikuje się do leczenia z intencją wyleczenia.
- •Rak piersi jest dodatni pod względem receptorów estrogenowych (ER+) i ujemny pod względem receptora HER2 (HER2-).
- •Przed rozpoczęciem badania zostanie określony status mutacji ESR1.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 3, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (99)
Medizinische Universität Innsbruck
Innsbruck, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Ordination Priv.-Doz. Dr. Michael Hubalek
Schwaz, Austria
Medical University of Vienna
Vienna, Austria
Tacchini Instituto de Pesquisa
Bento Gonçalves, Brazil
Hospital Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Brazil
Catarina Pesquisa Clínica - Neoplasias Litoral
Itajaí, Brazil
UPCO - Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
NOB Ondina
Salvador, Brazil
Masaryk Memorial Cancer Institute
Brno, Czechia
Multiscan Nemocnice Horovice
Hořovice, Czechia
University Hospital Olomouc
Olomouc, Czechia
General University Hospital Prague
Prague, Czechia
Tomas Bata Regional Hospital in Zlin
Zlín, Czechia
Polyclinique Bordeaux Nord Aquitaine
Bordeau, France
Institut Bergonié Bordeaux
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
Centre Hospitalier de Limoges
Limoges, France
CHU Lyon Sud
Lyon, France
Institut Paoli Calmettes
Marseille, France
APHP Tenon
Paris, France
Hospital prive des Cotes d'Amor
Plérin, France
CHU Saint Etienne
Saint-Priest-en-Jarez, France
IUCT Oncopole
Toulouse, France
Institute de Cancerologie de Lorraine - Nancy
Vandœuvre-lès-Nancy, France
MVZ Klinikum Aschaffenburg
Aschaffenburg, Germany
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Universitätsklinikum Dusseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, Germany
Klinikum Worms - Frauenklinik
Worms, Germany
University General Hospital Alexandroupoli
Alexandroupoli, Greece
251 Air Force General Hospital
Athens, Greece
Aretaeio Hospital
Athens, Greece
Attikon University Hospital
Athens, Greece
Metropolitan General Hospital 4th department
Athens, Greece
University General Hospital of Heraklion
Heraklion, Greece
University General Hospital of Larissa
Larissa, Greece
General University Hospital of Patras
Pátrai, Greece
Metropolitan Hospital Greece 1st department
Piraeus, Greece
EU Interbalkan Medical Center
Thessaloniki, Greece
Cliniche Gavazzeni
Bergamo, Italy
Azienda Ospedaliero-Universitaria (AOU) di Cagliari
Cagliari, Italy
Aou Careggi
Florence, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Ospedali Riuniti Livorno
Livorno, Italy
Instituto Europeo di Oncologia
Milan, Italy
AOU Policilinico Modena
Modena, Italy
IRCCS San Gerardo
Monza, Italy
Fondazione Pascale
Naples, Italy
Azienda Ospedaliero- Universitaria Maggiore Della Carita
Novara, Italy
Oncologia Medica AUSL Piacenza
Piacenza, Italy
Policlinico A. Gemelli IRCCS
Roma, Italy
Hospital Universitari Dexeus
Barcelona, Spain
Centro Oncológico de Galicia
A Coruña, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
A Coruña, Spain
Hospital General Universitario Dr. Balmis (Alicante)
Alicante, Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Institut Català d' Oncologia Badalona (ICO)
Badalona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Provincial de Castellón
Castellon, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Clínico San Cecilio de Granada
Granada, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Universitario de León
León, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Spain
Hospital Beata María Ana
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Sanchinarro-START-CIOCC
Madrid, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospitalario Universitario de Navarra
Pamplona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Quirónsalud Sagrado Corazón
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Hospital Universitario Marqués de Valdecilla
Valdecilla, Spain
Consorci Hospital General Universitari de València
Valencia, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitario La Ribera - Alzira
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Western General Hospital
Edinburgh, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Genesis Care Oxford
Oxford, United Kingdom
Royal Surrey County Hospital
Surrey Quays, United Kingdom
Royal Cornwall Hospital NHS Trust
Truro, United Kingdom
Genesis Cancer Care UK
Waterlooville, United Kingdom
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.