Testing two breast cancer drugs together for cancer that has spread to the brain
Official title: Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing whether two drugs, elacestrant and abemaciclib, can help people whose breast cancer has spread to the brain.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT05386108
- Stage of testing
- Phase 1/Phase 2
- Conditions studied
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases
Where it is running
This trial lists 86 sites.
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Andalusia
- University Hospital Reina Sofía (Córdoba)
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Belgium
- Antwerp University Hospital (Edegem)
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg (Leuven)
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc (Woluwe-Saint-Lambert)
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California
- Providence Medical Foundation (Fullerton)
- California Research Institute (Los Angeles)
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France
- Institut de Cancerologie de l'Ouest site Paul Papin (Angers)
- Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie (Brest)
- Centre Francois Baclesse - Oncologie Medicale - Cancerolo (Caen)
- Centre Jean Perrin (Clermont-Ferrand)
- Centre Léon Bérard - Département Oncologie Médicale (Lyon)
- Centre de Cancerologie du Grand Montpellier (Montpellier)
- Hôpital de la Pitiê Salpêtriêre (Paris)
- Centre Hospitalier Universitaire de Poitiers (Poitiers)
- Institut Claudius Regaud (Toulouse)
-
Germany
- Klinikum Bayreuth GmbH (Bayreuth)
- Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde (Cologne)
- Universitatsklinikum Carl Gustav Carus (Dresden)
- Universitaetsklinikum Duesseldorf (Düsseldorf)
- Universitätsklinikum Erlangen (Erlangen)
- Medizinische Hochschule Hannover (Hanover)
- Universitätsklinikum Leipzig (Leipzig)
- Klinikum Worms gGmbH (Worms)
- Helios Klinikum Wuppertal (Wuppertal)
-
Greece
- National and Capodistrian University of Athens - University General Hospital Attikon (Athens)
- Metropolitan Hospital [Oncology] (Piraeus)
- EUROMEDICA General Clinic of Thessaloniki (Thessaloniki)
- Interbalkan European Medical Center (Thessaloniki)
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Illinois
- Carle Cancer Center (Urbana)
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Italy
- AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi (Ancona)
- Istituto di Candiolo, IRCCS (Candiolo)
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS (Meldola)
- A. O. Ospedali Riuniti Parpardo, Piemonte, Messina (Messina)
- IEO - Istituto Europeo di Oncologia, IRCCS (Milan)
- Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena (Modena)
- Ospedale San Gerardo, ASST di Monza, IRCCS (Monza)
- Azienda Ospedaliera Universitaria Federico II (Naples)
- Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS (Naples)
- Istituto Oncologico Veneto IOV - IRCCS (Padova)
- IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo (Pavia)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Roma)
- and 2 more in Italy
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Madrid
- University Hospital Ramón y Cajal (Madrid)
- University Hospital 12 de Octubre (Madrid)
- Clara Campal Comprehensive Cancer Center (CIOCC) (Madrid)
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Massachusetts
- Dana-Farber Cancer Institute (Boston)
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Michigan
- Henry Ford Hospital (Detroit)
-
Murcia
- University Clinical Hospital Virgen de la Arrixaca (El Palmar)
-
Ohio
- Miami Valley Hospital South (Centerville)
-
Oregon
- Oregon Health & Science University (Portland)
-
South Korea
- Asan Medical Center (Seoul)
- Gangnam Severance Hospital (Seoul)
- Samsung Medical Center (Seoul)
- Ewha Womans University MokDong Hospital (Seoul)
- Seoul National University Bundang Hospital (Seoul)
- Seoul National University Hospital (Seoul)
-
Spain
- Hospital Clinic De Barcelona (Barcelona)
- Hospital Universitari Vall D Hebron (Barcelona)
- Clinica Universidad de Navarra (Madrid)
- Hospital Clínico San Carlos (Madrid)
- Hospital Universitario Quirónsalud Madrid (Madrid)
- Clinica Universidad de Navarra (Pamplona)
- Complexo Hospitalario Universitario De Santiago (Santiago de Compostela)
- Fundación Instituto Valenciano De Oncología (Valencia)
- Hospital Universitario Virgen del Rocío (Valencia)
-
Tennessee
- SCRI Oncology Partners (Nashville)
-
Texas
- University of Texas MD Anderson Cancer Center (Houston)
- UT Health San Antonio University of Texas (San Antonio)
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Turkey (Türkiye)
- Adana Sehir Hastanesi (Adana)
- Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi (Ankara)
- Ankara University Medical Faculty (Ankara)
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi (Ankara)
- Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi (Ankara)
- Hacettepe University Medical Faculty (Ankara)
- Memorial Ankara Hastanesi Tibbi Onkoloji (Ankara)
- Ege University Medical Faculty (Bornova)
- Acibadem Altunizade Hospital (Istanbul)
- Medipol Mega Hospital - Medical Oncology (Istanbul)
- Prof. Dr. Suleyman Yalcin Sehir Hastanesi (Istanbul)
-
United Kingdom
- University Hospitals of Leicester NHS Trust -Glenfield Hospital (Leicester)
- The Clatterbridge Cancer Centre NHS Foundation Trust (Liverpool)
- Guy's and St Thomas' NHS Foundation Trust (London)
- University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre (London)
- The Christie NHS Foundation Trust - Medical Oncology (Manchester)
-
Virginia
- Virginia Cancer Institute (Norfolk)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.