Actively Recruiting
An Open-label Multicenter Phase 1b-2 Study of Elacestrant with Abemaciclib in Women and Men With Brain Metastases From ER-Positive, HER-2 Negative Breast Cancer
Led by Stemline Therapeutics, Inc. · Updated on 2026-06-04
73
Participants Needed
86
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of elacestrant and abemaciclib in adults with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. This global, open-label study includes a phase 1b part to find the best dose for phase 2, followed by a phase 2 part that tests these drugs together in participants with active brain metastases from this type of breast cancer. Participants receive elacestrant at doses of 300 mg or 400 mg once daily, combined with abemaciclib at doses of 100 mg or 150 mg twice daily. Phase 1b evaluates three dose combinations to select the recommended phase 2 dose (RP2D). Phase 2 participants receive the combination at the selected RP2D. Treatment continues in cycles of 28 days. During the study, participants are monitored for treatment response and safety. Researchers perform imaging to measure brain and other tumor sites, assess quality of life, and evaluate neurological and cognitive function at regular intervals over up to three years. Blood samples are taken to study drug levels. Participants' adverse events and overall survival are also tracked to understand how the treatments work and their effects.
CONDITIONS
Brief Title
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study activities
- Women or men aged 18 years or older at consent
- Female participants either postmenopausal or pre/perimenopausal receiving LHRH agonist
- ER-positive tumor with ≥1% staining and HER-2 negative tumor per local lab testing
- In phase 2, at least one active and measurable brain metastasis per RECIST 1.1
- In phase 1b, brain metastases allowed but not required; at least one measurable lesion outside brain
- Stable or decreasing corticosteroid dose ≤4 mg dexamethasone or equivalent for 7 days prior to baseline
- No more than one seizure within 4 weeks before starting trial therapy
- Prior metastatic therapy includes at least one endocrine therapy, up to two chemotherapy regimens, and up to two prior CDK 4/6 inhibitor lines excluding abemaciclib
- Documented disease progression or recurrence after prior therapy
- ECOG performance status 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, kidney, liver, and electrolyte function as defined by lab values
- Willing and able to follow study visit schedule and protocol requirements
You will not qualify if you...
- Need for immediate central nervous system-specific treatment
- Imminent organ failure or visceral crisis
- Leptomeningeal metastases with positive CSF cytology or clinical/radiologic evidence
- Breast cancer treatment-naïve in advanced/metastatic setting
- History of pulmonary embolism, stroke, or heart attack within 6 months
- Prior abemaciclib therapy in metastatic setting
- Prior elacestrant or similar investigational agents in metastatic setting
- Concurrent malignancy within 3 years except certain treated cancers
- Currently in another breast cancer intervention trial
- Recent anti-cancer or investigational drug treatments within specified time frames
- Radiation therapy within 7 days before starting study drug or incomplete recovery
- Uncontrolled active infections; HIV+ or hepatitis B/C with undetectable viral load allowed
- Major surgery within 4 weeks before trial therapy
- Inability to take oral medication or uncontrolled gastrointestinal conditions
- Females of childbearing potential not agreeing to effective contraception
- Males not agreeing to barrier contraception or sperm restrictions
- Pregnant or breastfeeding females
- Known intolerance to study drugs or their components
- Use of strong/moderate CYP3A4 inducers/inhibitors or specified herbal supplements shortly before trial
- Vaccination within 7 days before randomization
- Severe medical or psychiatric conditions preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive treatment with Elacestrant and Abemaciclib according to their assigned cohort dosing schedule.
Regular visits for treatment and monitoring during each 28-day cycle
Duration - Up to 3 years
Participants are monitored for safety, response, and survival outcomes after treatment ends.
Visits scheduled periodically during follow-up up to 3 years
Trial Site Locations
Total: 86 locations
1
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
2
California Research Institute
Los Angeles, California, United States, 90027
Actively Recruiting
3
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
6
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Completed
8
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
UT Health San Antonio University of Texas
San Antonio, Texas, United States, 78229
Completed
11
Virginia Cancer Institute
Norfolk, Virginia, United States, 00115
Actively Recruiting
12
Antwerp University Hospital
Edegem, Belgium, 2650
Actively Recruiting
13
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
Actively Recruiting
14
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Actively Recruiting
15
Institut de Cancerologie de l'Ouest site Paul Papin
Angers, France
Actively Recruiting
16
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
Brest, France
Actively Recruiting
17
Centre Francois Baclesse - Oncologie Medicale - Cancerolo
Caen, France
Actively Recruiting
18
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
19
Centre Léon Bérard - Département Oncologie Médicale
Lyon, France
Actively Recruiting
20
Centre de Cancerologie du Grand Montpellier
Montpellier, France, 37070
Actively Recruiting
21
Hôpital de la Pitiê Salpêtriêre
Paris, France, 75103
Actively Recruiting
22
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86000
Actively Recruiting
23
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
24
Klinikum Bayreuth GmbH
Bayreuth, Germany, 95445
Actively Recruiting
25
Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde
Cologne, Germany
Completed
26
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Actively Recruiting
27
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany
Actively Recruiting
28
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
29
Medizinische Hochschule Hannover
Hanover, Germany
Actively Recruiting
30
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
31
Klinikum Worms gGmbH
Worms, Germany, 67550
Actively Recruiting
32
Helios Klinikum Wuppertal
Wuppertal, Germany
Actively Recruiting
33
National and Capodistrian University of Athens - University General Hospital Attikon
Athens, Greece, 12462
Actively Recruiting
34
Metropolitan Hospital [Oncology]
Piraeus, Greece, 12462
Actively Recruiting
35
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, Greece, 54645
Completed
36
Interbalkan European Medical Center
Thessaloniki, Greece, 57001
Actively Recruiting
37
AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi
Ancona, Italy
Actively Recruiting
38
Istituto di Candiolo, IRCCS
Candiolo, Italy
Actively Recruiting
39
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
Meldola, Italy
Actively Recruiting
40
A. O. Ospedali Riuniti Parpardo, Piemonte, Messina
Messina, Italy
Actively Recruiting
41
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy
Actively Recruiting
42
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
Modena, Italy
Actively Recruiting
43
Ospedale San Gerardo, ASST di Monza, IRCCS
Monza, Italy
Actively Recruiting
44
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Actively Recruiting
45
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Naples, Italy
Actively Recruiting
46
Istituto Oncologico Veneto IOV - IRCCS
Padova, Italy
Actively Recruiting
47
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
48
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
49
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy
Actively Recruiting
50
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Torino, Italy
Actively Recruiting
51
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
52
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
53
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
54
Ewha Womans University MokDong Hospital
Seoul, South Korea, 07985
Actively Recruiting
55
Seoul National University Bundang Hospital
Seoul, South Korea
Actively Recruiting
56
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
57
University Hospital Reina Sofía
Córdoba, Andalusia, Spain, 14004
Actively Recruiting
58
University Hospital Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
59
University Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
60
Clara Campal Comprehensive Cancer Center (CIOCC)
Madrid, Madrid, Spain, 28050
Actively Recruiting
61
University Clinical Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
62
Hospital Clinic De Barcelona
Barcelona, Spain, 08036
Actively Recruiting
63
Hospital Universitari Vall D Hebron
Barcelona, Spain
Actively Recruiting
64
Clinica Universidad de Navarra
Madrid, Spain
Actively Recruiting
65
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
66
Hospital Universitario Quirónsalud Madrid
Madrid, Spain
Actively Recruiting
67
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
68
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
69
Fundación Instituto Valenciano De Oncología
Valencia, Spain
Actively Recruiting
70
Hospital Universitario Virgen del Rocío
Valencia, Spain
Actively Recruiting
71
Adana Sehir Hastanesi
Adana, Turkey (Türkiye)
Actively Recruiting
72
Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Actively Recruiting
73
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Actively Recruiting
74
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Actively Recruiting
75
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Actively Recruiting
76
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Actively Recruiting
77
Memorial Ankara Hastanesi Tibbi Onkoloji
Ankara, Turkey (Türkiye)
Actively Recruiting
78
Ege University Medical Faculty
Bornova, Turkey (Türkiye)
Actively Recruiting
79
Acibadem Altunizade Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
80
Medipol Mega Hospital - Medical Oncology
Istanbul, Turkey (Türkiye)
Actively Recruiting
81
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye)
Actively Recruiting
82
University Hospitals of Leicester NHS Trust -Glenfield Hospital
Leicester, United Kingdom
Withdrawn
83
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Withdrawn
84
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
85
University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre
London, United Kingdom
Actively Recruiting
86
The Christie NHS Foundation Trust - Medical Oncology
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Stemline Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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