New hope for breast cancer patients with brain tumors: drug combo trial underway

NCT ID NCT05386108

Disease control Sponsor: Stemline Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests a combination of two drugs, elacestrant and abemaciclib, in people with a specific type of breast cancer (ER-positive, HER2-negative) that has spread to the brain. The goal is to see if the combination can shrink or control brain tumors. The trial involves about 73 adults and is currently recruiting at multiple sites worldwide.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 73 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant has the signed informed consent form before any study-related activities according to local guidelines. 2. Women or men aged ≥18 years, at the time of informed consent signature. * Female participants may be either postmenopausal or pre/perimenopausal. Postmenopausal status is defined by: 1. Age ≥60 years 2. Age \<60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges 3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy). * Pre-menopausal / peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study. 3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner: * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing 4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1. * Any of the following qualifies brain metastases as active: 1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy. 2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy. 3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy. * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \[mm\] by computed tomography \[CT\] or magnetic resonance imaging \[MRI\]). * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required. 5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent. 6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy. 7. Participants' prior therapy received in the metastatic setting includes: * At least one endocrine therapy * Up to two chemotherapy regimens * Up to two lines of prior cyclin-dependent kinase (CDK) 4/6 inhibitor, not including abemaciclib Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2). Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen. 8. Participant has documented intracranial and/or extracranial radiological progression or recurrence while on or after the most recent therapy. 9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 10. Participant has a life expectancy ≥ 12 weeks. 11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values: 1. Absolute neutrophil count (ANC) ≥1.5 × 10\^9/liter (L) 2. Platelets ≥100 × 10\^9/L 3. Hemoglobin ≥9.0 grams (g)/deciliter (dL) 4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment) 5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL/minute 6. Serum albumin ≥3.0 g/dL (≥30 g/L) 7. Liver function tests: In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN. 8. Total serum bilirubin \<1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN 12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: 1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment. 2. Participant has imminent organ failure and/or visceral crisis. 3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted. 4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced/metastatic setting. 5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit. 6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence. 7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting. 8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor. 9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy. 10. Prior anti-cancer or investigational drug treatment within the following windows: * Fulvestrant treatment (last injection) \<42 days before first dose of study drug * Any other endocrine therapy \<14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy. * Chemotherapy or other anti-cancer therapy \<14 days before first dose of study drug * Any investigational anti-cancer drug therapy within \<28 days or \<5 half lives, whichever is shorter * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \<1 month prior to first dose of study drug according to institutional guidelines. 11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects. 12. Uncontrolled significant active infections * Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline. 13. Major surgery within 4 weeks of starting trial therapy. 14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs. 15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following: 1. Intrauterine device (non-hormonal) 2. Sexual abstinence 3. Bilateral tubal occlusion/ligation 4. Have a vasectomized partner with confirmed azoospermia. 16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception. 17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose. 18. Known intolerance to either study drug or any of their excipients. 19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy: 1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \<5 half-lives, whichever is shorter) 2. Herbal preparations/medications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy 3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization. 20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.

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Conditions

The condition(s) this trial relates to.

brain cancer brain disorder brain neoplasm breast disorder breast neoplasm central nervous system cancer central nervous system disorder central nervous system neoplasm hormone receptor-positive breast cancer neoplasm Neoplasms by Site

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain diseases Brain neoplasms Breast diseases Breast neoplasms Central nervous system diseases Central nervous system neoplasms Neoplasms Neoplasms by site

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

80 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

A. O. Ospedali Riuniti Parpardo, Piemonte, Messina
RECRUITING

Messina, Italy
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
RECRUITING

Torino, Italy
AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi
RECRUITING

Ancona, Italy
Acibadem Altunizade Hospital
RECRUITING

Istanbul, Turkey (Türkiye)
Adana Sehir Hastanesi
RECRUITING

Adana, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
RECRUITING

Ankara, Turkey (Türkiye)
Ankara University Medical Faculty
RECRUITING

Ankara, Turkey (Türkiye)
Antwerp University Hospital
RECRUITING

Edegem, 2650, Belgium
Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
Azienda Ospedaliera Santa Maria di Terni
RECRUITING

Terni, Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING

Naples, Italy
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
RECRUITING

Modena, Italy
California Research Institute
RECRUITING

Los Angeles, California, 90027, United States
Carle Cancer Center
RECRUITING

Urbana, Illinois, 61801, United States
Centre Francois Baclesse - Oncologie Medicale - Cancerolo
RECRUITING

Caen, France
Centre Hospitalier Universitaire de Poitiers
RECRUITING

Poitiers, 86000, France
Centre Jean Perrin
RECRUITING

Clermont-Ferrand, France
Centre Léon Bérard - Département Oncologie Médicale
RECRUITING

Lyon, France
Centre de Cancerologie du Grand Montpellier
RECRUITING

Montpellier, 37070, France
Clara Campal Comprehensive Cancer Center (CIOCC)
RECRUITING

Madrid, Madrid, 28050, Spain
Clinica Universidad de Navarra
RECRUITING

Madrid, Spain
Clinica Universidad de Navarra
RECRUITING

Pamplona, Spain
Complexo Hospitalario Universitario De Santiago
RECRUITING

Santiago de Compostela, 15706, Spain
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
RECRUITING

Ankara, Turkey (Türkiye)
EUROMEDICA General Clinic of Thessaloniki
COMPLETED

Thessaloniki, 54645, Greece
Ege University Medical Faculty
RECRUITING

Bornova, Turkey (Türkiye)
Ewha Womans University MokDong Hospital
RECRUITING

Seoul, 07985, South Korea
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Roma, Italy
Fundación Instituto Valenciano De Oncología
RECRUITING

Valencia, Spain
Gangnam Severance Hospital
RECRUITING

Seoul, 06273, South Korea
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
RECRUITING

Ankara, Turkey (Türkiye)
Guy's and St Thomas' NHS Foundation Trust
RECRUITING

London, United Kingdom
Hacettepe University Medical Faculty
RECRUITING

Ankara, Turkey (Türkiye)
Helios Klinikum Wuppertal
RECRUITING

Wuppertal, Germany
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Hospital Clinic De Barcelona
RECRUITING

Barcelona, 08036, Spain
Hospital Clínico San Carlos
RECRUITING

Madrid, Spain
Hospital Universitari Vall D Hebron
RECRUITING

Barcelona, Spain
Hospital Universitario Quirónsalud Madrid
RECRUITING

Madrid, Spain
Hospital Universitario Virgen del Rocío
RECRUITING

Valencia, Spain
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
RECRUITING

Brest, France
Hôpital de la Pitiê Salpêtriêre
RECRUITING

Paris, 75103, France
IEO - Istituto Europeo di Oncologia, IRCCS
RECRUITING

Milan, Italy
INOC - Istituto Nazionale Oncologico Candiolo
RECRUITING

Candiolo, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo
RECRUITING

Pavia, Italy
Institut Claudius Regaud
RECRUITING

Toulouse, 31100, France
Institut de Cancerologie de l'Ouest site Paul Papin
RECRUITING

Angers, France
Interbalkan European Medical Center
RECRUITING

Thessaloniki, 57001, Greece
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
RECRUITING

Naples, Italy
Istituto Oncologico Veneto IOV - IRCCS
RECRUITING

Padova, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
RECRUITING

Meldola, Italy
Klinikum Bayreuth GmbH
RECRUITING

Bayreuth, 95445, Germany
Klinikum Worms gGmbH
RECRUITING

Worms, 67550, Germany
Medipol Mega Hospital - Medical Oncology
RECRUITING

Istanbul, Turkey (Türkiye)
Medizinische Hochschule Hannover
RECRUITING

Hanover, Germany
Memorial Ankara Hastanesi Tibbi Onkoloji
RECRUITING

Ankara, Turkey (Türkiye)
Metropolitan Hospital [Oncology]
RECRUITING

Piraeus, 12462, Greece
Miami Valley Hospital South
RECRUITING

Centerville, Ohio, 45459, United States
National and Capodistrian University of Athens - University General Hospital Attikon
RECRUITING

Athens, 12462, Greece
Oregon Health & Science University
COMPLETED

Portland, Oregon, 97239, United States
Ospedale San Gerardo, ASST di Monza, IRCCS
RECRUITING

Monza, Italy
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
RECRUITING

Istanbul, Turkey (Türkiye)
Providence Medical Foundation
RECRUITING

Fullerton, California, 92835, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Seoul National University Bundang Hospital
RECRUITING

Seoul, South Korea
Seoul National University Hospital
RECRUITING

Seoul, South Korea
The Christie NHS Foundation Trust - Medical Oncology
RECRUITING

Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
WITHDRAWN

Liverpool, United Kingdom
UT Health San Antonio University of Texas
COMPLETED

San Antonio, Texas, 78229, United States
Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde
COMPLETED

Cologne, Germany
Universitaetsklinikum Duesseldorf
RECRUITING

Düsseldorf, Germany
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
RECRUITING

Leuven, Belgium
Universitatsklinikum Carl Gustav Carus
RECRUITING

Dresden, Germany
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
RECRUITING

Woluwe-Saint-Lambert, Belgium
University Clinical Hospital Virgen de la Arrixaca
RECRUITING

El Palmar, Murcia, 30120, Spain
University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre
RECRUITING

London, United Kingdom
University Hospital 12 de Octubre
RECRUITING

Madrid, Madrid, 28041, Spain
University Hospital Ramón y Cajal
RECRUITING

Madrid, Madrid, 28034, Spain
University Hospital Reina Sofía
RECRUITING

Córdoba, Andalusia, 14004, Spain
University Hospitals of Leicester NHS Trust -Glenfield Hospital
WITHDRAWN

Leicester, United Kingdom
University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Universitätsklinikum Erlangen
RECRUITING

Erlangen, Germany
Universitätsklinikum Leipzig
RECRUITING

Leipzig, Germany
Virginia Cancer Institute
RECRUITING

Norfolk, Virginia, 00115, United States

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