Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
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 is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana zgoda na uczestnictwo w badaniu przed rozpoczęciem jakichkolwiek działań związanych z badaniem.
- •Wiek co najmniej 18 lat w momencie podpisania zgody.
- •Dla kobiet: okres pomenopauzalny (wiek ≥60 lat, lub <60 lat bez miesiączki przez 12+ miesięcy, lub po usunięciu jajników) lub przyjmowanie leku LHRH przez co najmniej 3-4 tygodnie przed badaniem.
- •Potwierdzony typ nowotworu dodatni do receptorów estrogenowych (ER+) i ujemny dla HER-2 w badaniu laboratoryjnym.
- •W fazie II: co najmniej jeden aktywny przerzut do mózgu o wymiarze ≥10 mm widoczny w tomografii.
- •W fazie I b: co najmniej jeden mierzalny guz poza mózgiem.
- •Jeśli pacjent przyjmuje kortykosteroidy: stała lub zmniejszająca się dawka przez co najmniej 7 dni przed badaniem, nie wyższa niż 4 mg deksametazonu dziennie.
- •Maksymalnie jeden napad padaczki w ciągu 4 tygodni przed badaniem; wcześniej zastosowana co najmniej jedna terapia hormonalna i do dwóch linii chemioterapii.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (86)
Providence Medical Foundation
Fullerton, United States
California Research Institute
Los Angeles, United States
Carle Cancer Center
Urbana, United States
Dana-Farber Cancer Institute
Boston, United States
Henry Ford Hospital
Detroit, United States
Miami Valley Hospital South
Centerville, United States
Oregon Health & Science University
Portland, United States
SCRI Oncology Partners
Nashville, United States
University of Texas MD Anderson Cancer Center
Houston, United States
UT Health San Antonio University of Texas
San Antonio, United States
Virginia Cancer Institute
Norfolk, United States
Antwerp University Hospital
Edegem, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Institut de Cancerologie de l'Ouest site Paul Papin
Angers, France
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
Brest, France
Centre Francois Baclesse - Oncologie Medicale - Cancerolo
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Léon Bérard - Département Oncologie Médicale
Lyon, France
Centre de Cancerologie du Grand Montpellier
Montpellier, France
Hôpital de la Pitiê Salpêtriêre
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Institut Claudius Regaud
Toulouse, France
Klinikum Bayreuth GmbH
Bayreuth, Germany
Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde
Cologne, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum Worms gGmbH
Worms, Germany
Helios Klinikum Wuppertal
Wuppertal, Germany
National and Capodistrian University of Athens - University General Hospital Attikon
Athens, Greece
Metropolitan Hospital [Oncology]
Piraeus, Greece
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, Greece
Interbalkan European Medical Center
Thessaloniki, Greece
AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi
Ancona, Italy
Istituto di Candiolo, IRCCS
Candiolo, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
Meldola, Italy
A. O. Ospedali Riuniti Parpardo, Piemonte, Messina
Messina, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
Modena, Italy
Ospedale San Gerardo, ASST di Monza, IRCCS
Monza, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Naples, Italy
Istituto Oncologico Veneto IOV - IRCCS
Padova, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Torino, Italy
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ewha Womans University MokDong Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
University Hospital Reina Sofía
Córdoba, Spain
University Hospital Ramón y Cajal
Madrid, Spain
University Hospital 12 de Octubre
Madrid, Spain
Clara Campal Comprehensive Cancer Center (CIOCC)
Madrid, Spain
University Clinical Hospital Virgen de la Arrixaca
El Palmar, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Quirónsalud Madrid
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain
Fundación Instituto Valenciano De Oncología
Valencia, Spain
Hospital Universitario Virgen del Rocío
Valencia, Spain
Adana Sehir Hastanesi
Adana, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi Tibbi Onkoloji
Ankara, Turkey (Türkiye)
Ege University Medical Faculty
Bornova, Turkey (Türkiye)
Acibadem Altunizade Hospital
Istanbul, Turkey (Türkiye)
Medipol Mega Hospital - Medical Oncology
Istanbul, Turkey (Türkiye)
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye)
University Hospitals of Leicester NHS Trust -Glenfield Hospital
Leicester, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre
London, United Kingdom
The Christie NHS Foundation Trust - Medical Oncology
Manchester, United Kingdom
Trial contact
Stemline Trials
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.