Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer (ELECTRA)

June 3, 2026 updated by: Stemline Therapeutics, Inc.

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

73

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Konstantinos Papadimitriou
      • Leuven, Belgium
        • Recruiting
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
        • Principal Investigator:
          • Patrick Neven
      • Woluwe-Saint-Lambert, Belgium
        • Recruiting
        • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Francois Duhoux
  • France
      • Angers, France
        • Recruiting
        • Institut de Cancerologie de l'Ouest site Paul Papin
        • Principal Investigator:
          • Paule Augereau
      • Brest, France
        • Recruiting
        • Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
        • Principal Investigator:
          • Laura Deiana
      • Caen, France
        • Recruiting
        • Centre Francois Baclesse - Oncologie Medicale - Cancerolo
        • Principal Investigator:
          • George Emile
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Jean Perrin
        • Principal Investigator:
          • Marie-Ange Mouret-Reynier
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard - Département Oncologie Médicale
        • Principal Investigator:
          • Louis Larrouquere
      • Montpellier, France, 37070
        • Recruiting
        • Centre de Cancerologie du Grand Montpellier
        • Principal Investigator:
          • Cristian Villanueva
      • Paris, France, 75103
        • Recruiting
        • Hopital de la Pitie Salpetriere
        • Principal Investigator:
          • Tichoue Herve Foka
      • Poitiers, France, 86000
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • Nicolas Isambert
      • Toulouse, France, 31100
        • Recruiting
        • Institut Claudius Regaud
        • Principal Investigator:
          • Florence Dalenc
  • Germany
      • Bayreuth, Germany, 95445
        • Recruiting
        • Klinikum Bayreuth GmbH
        • Principal Investigator:
          • Christoph Mundhenke
      • Cologne, Germany
        • Completed
        • Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde
      • Dresden, Germany
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
        • Principal Investigator:
          • Pauline Wimberger
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Duesseldorf
        • Principal Investigator:
          • Tanja Fehm
      • Erlangen, Germany
        • Recruiting
        • Universitätsklinikum Erlangen
        • Principal Investigator:
          • Peter Fasching
      • Hanover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Tjoung-Won Park-Simon
      • Leipzig, Germany
        • Recruiting
        • Universitätsklinikum Leipzig
        • Principal Investigator:
          • Dirk Forstmeyer
      • Worms, Germany, 67550
        • Recruiting
        • Klinikum Worms gGmbH
        • Principal Investigator:
          • Eva Werner
      • Wuppertal, Germany
        • Recruiting
        • Helios Klinikum Wuppertal
        • Principal Investigator:
          • Vesna Bjelic-Radisic
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • National and Capodistrian University of Athens - University General Hospital Attikon
        • Principal Investigator:
          • Anna Koumarianou
      • Piraeus, Greece, 12462
        • Recruiting
        • Metropolitan Hospital [Oncology]
        • Principal Investigator:
          • Eleni Linardou
      • Thessaloniki, Greece, 54645
        • Completed
        • EUROMEDICA General Clinic of Thessaloniki
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Interbalkan European Medical Center
        • Principal Investigator:
          • Sofia Baka
  • Italy
      • Ancona, Italy
        • Recruiting
        • AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi
        • Principal Investigator:
          • Rossana Berardi
      • Candiolo, Italy
        • Recruiting
        • Istituto di Candiolo, IRCCS
        • Principal Investigator:
          • Vanesa Gregorc
      • Meldola, Italy
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
        • Principal Investigator:
          • Michela Palleschi
      • Messina, Italy
        • Recruiting
        • A. O. Ospedali Riuniti Parpardo, Piemonte, Messina
        • Principal Investigator:
          • Ricciardi Giuseppina
      • Milan, Italy
        • Recruiting
        • IEO - Istituto Europeo di Oncologia, IRCCS
        • Principal Investigator:
          • Giuseppe Curigliano
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
        • Principal Investigator:
          • Annalisa Fontana
      • Monza, Italy
        • Recruiting
        • Ospedale San Gerardo, ASST di Monza, IRCCS
        • Principal Investigator:
          • Marina Cazzaniga
      • Naples, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Principal Investigator:
          • Mario Giuliano
      • Naples, Italy
        • Recruiting
        • Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
        • Principal Investigator:
          • Michelino De Laurentiis
      • Padova, Italy
        • Recruiting
        • Istituto Oncologico Veneto IOV - IRCCS
        • Principal Investigator:
          • Valentina Guarneri
      • Pavia, Italy
        • Recruiting
        • IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo
        • Principal Investigator:
          • Angioletta Lasagna
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Principal Investigator:
          • Alessandra Fabi
      • Terni, Italy
        • Recruiting
        • Azienda Ospedaliera Santa Maria di Terni
        • Principal Investigator:
          • Jennifer Foglietta
      • Torino, Italy
        • Recruiting
        • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
        • Principal Investigator:
          • Massimiliano Icardi
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Sung-Bae Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Ji-Yeon Kim
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Kyung-Hun Lee
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Principal Investigator:
          • Jee Hung Kim
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Jee Hyun Kim
      • Seoul, South Korea, 07985
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Principal Investigator:
          • Kyoung-Eun Lee
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Milana Bergamino
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d Hebron
        • Principal Investigator:
          • Esther Zamora Adelantado
      • Madrid, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Marta Santisteban Eslava
      • Madrid, Spain
        • Recruiting
        • Hospital Clínico San Carlos
        • Principal Investigator:
          • José García Sáenz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
        • Principal Investigator:
          • Jesus Fuentes Antras
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Marta Santisteban Eslava
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Complexo Hospitalario Universitario De Santiago
        • Principal Investigator:
          • Rafael Lopez Lopez
      • Valencia, Spain
        • Recruiting
        • Fundación Instituto Valenciano de Oncología
        • Principal Investigator:
          • Joaquin Gavilá Gregori
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Manuel Ruiz Borrego
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Recruiting
        • University Hospital Reina Sofía
        • Principal Investigator:
          • Juan Rafael De La Haba Rodriguez
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • University Hospital 12 de Octubre
        • Principal Investigator:
          • Eva Ciruelos Gil
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • University Hospital Ramón y Cajal
        • Principal Investigator:
          • Elena Lopez Miranda
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • Clara Campal Comprehensive Cancer Center (CIOCC)
        • Principal Investigator:
          • Raquel Bratos Lorenzo
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • University Clinical Hospital Virgen de la Arrixaca
        • Principal Investigator:
          • Jose Luis Alonso Romero
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Recruiting
        • Adana Şehir Hastanesi
        • Principal Investigator:
          • Timucin Cil
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Hacettepe University Medical Faculty
        • Principal Investigator:
          • Sercan Aksoy
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
        • Principal Investigator:
          • Mehmet Sendur
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara University Medical Faculty
        • Principal Investigator:
          • Yuksel Urun
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
        • Principal Investigator:
          • Cengiz Karacin
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
        • Principal Investigator:
          • Nuri Karadurmus
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Memorial Ankara Hastanesi Tibbi Onkoloji
        • Principal Investigator:
          • Umut Demirci
      • Bornova, Turkey (Türkiye)
        • Recruiting
        • Ege University Medical Faculty
        • Principal Investigator:
          • Erhan Gokmen
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Prof. Dr. Suleyman Yalcin Sehir Hastanesi
        • Principal Investigator:
          • Mahmut Gumus
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Acibadem Altunizade Hospital
        • Principal Investigator:
          • Gul Basaran
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Medipol Mega Hospital - Medical Oncology
        • Principal Investigator:
          • Ahmet Bilici
  • United Kingdom
      • Leicester, United Kingdom
        • Withdrawn
        • University Hospitals of Leicester NHS Trust -Glenfield Hospital
      • Liverpool, United Kingdom
        • Withdrawn
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Angela Swampillai
      • London, United Kingdom
        • Recruiting
        • University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre
        • Principal Investigator:
          • Elisavet Papadimitraki
        • Contact:
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust - Medical Oncology
        • Principal Investigator:
          • Ciara O'Brien
        • Contact:
        • Contact:
          • Phone Number: 44 161 918 2352
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Monica Lee
      • Los Angeles, California, United States, 90027
        • Recruiting
        • California Research Institute
        • Principal Investigator:
          • Ghassan Al-Jazavrly
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Kendrith Rowland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Nancy Lin
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Haythem Ali
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Principal Investigator:
          • Jhansi Koduri
    • Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health & Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Principal Investigator:
          • Denise Yardley
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Nuhad Ibrahim
      • San Antonio, Texas, United States, 78229
        • Completed
        • UT Health San Antonio University of Texas
    • Virginia
      • Norfolk, Virginia, United States, 00115
        • Recruiting
        • Virginia Cancer Institute
        • Principal Investigator:
          • Michael Danso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1b Cohort 3
Elacestrant 400 mg QD + abemaciclib 150 mg BID
Drug: Elacestrant
300 mg, 400 mg
Other Names:
  • Orserdu
  • ER-306323
  • Elacestrant dihydrochloride
  • RAD-1901
Drug: Abemaciclib
100 mg, 150 mg
Other Names:
  • Verzenio
Experimental: Phase 1b Cohort 2
Elacestrant 400 mg QD + abemaciclib 100 mg BID
Drug: Elacestrant
300 mg, 400 mg
Other Names:
  • Orserdu
  • ER-306323
  • Elacestrant dihydrochloride
  • RAD-1901
Drug: Abemaciclib
100 mg, 150 mg
Other Names:
  • Verzenio
Experimental: Phase 1b Cohort 1
Elacestrant 300 milligrams (mg) once daily (QD) + abemaciclib 100 mg twice daily (BID)
Drug: Elacestrant
300 mg, 400 mg
Other Names:
  • Orserdu
  • ER-306323
  • Elacestrant dihydrochloride
  • RAD-1901
Drug: Abemaciclib
100 mg, 150 mg
Other Names:
  • Verzenio
Experimental: Phase 2
Elacestrant in combination with abemaciclib at the RP2D determined in Phase 1b
Drug: Elacestrant
300 mg, 400 mg
Other Names:
  • Orserdu
  • ER-306323
  • Elacestrant dihydrochloride
  • RAD-1901
Drug: Abemaciclib
100 mg, 150 mg
Other Names:
  • Verzenio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: RP2D
Time Frame: Cycle 1 (28 days)
Based on the observed number of dose-limiting toxicities (DLTs) during the first cycle. Dose-limiting toxicity is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs will be evaluated during the first cycle (28 days) of treatment in up to 3 cohorts during Phase 1b. A DLT will be defined as any of the toxicities listed in the protocol that are not clearly due to breast cancer or extraneous causes.
Cycle 1 (28 days)
Phase 2: Objective Response Rate (ORR) Per Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Time Frame: 3 years
Defined as the proportion of participants with a best overall response (BOR) of either a confirmed complete response (CR) or partial response (PR) per blinded independent central review (BICR).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 3 years
3 years
Phase 1b and 2: Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)
Time Frame: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Phase 1b and 2: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Phase 1b and 2: Time to Reach Cmax (Tmax)
Time Frame: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)
Phase 1b: ORR As Per Local Investigator's Assessment and Per BICR
Time Frame: 3 years
3 years
Phase 1b: Duration of Response (DoR) As Per Local Investigator's Assessment and Per BICR
Time Frame: 3 years
3 years
Phase 1b: Clinical Benefit Rate (CBR) at 16 Weeks As Per Local Investigator's Assessment and Per BICR
Time Frame: 16 weeks
16 weeks
Phase 1b: CBR at 24 Weeks As Per Local Investigator's Assessment and Per BICR
Time Frame: 24 weeks
24 weeks
Phase 1b: Progression-free Survival (PFS) As Per Local Investigator's Assessment and Per BICR
Time Frame: 3 years
3 years
Phase 1b: Overall Survival (OS)
Time Frame: 3 years
3 years
Phase 2: Intracranial Objective Response Rate (iORR) per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) (iORR-RANO)
Time Frame: 3 years
Defined as the proportion of participants achieving a best overall intracranial response of confirmed PR + CR, based on intracranial lesions.
3 years
Phase 2: iORR Per Intracranial RECIST V1.1 (iORR-RECIST)
Time Frame: 3 years
Defined as the proportion of participants achieving a best overall intracranial response of confirmed PR + CR, per BICR.
3 years
Phase 2: DOR Per Overall RECIST V1.1
Time Frame: 3 years
Defined as the duration of time from the date when criteria are met for either a CR or PR, per BICR, until the first date that progressive disease is objectively documented (intracranial or overall according to RANO-BM or RECIST version 1.1).
3 years
Phase 2: Intracranial DoR Per RANO-BM (iDoR-RANO)
Time Frame: 3 years
Defined as the duration of time from the date when criteria are met for either a CR or PR per BICR, until the first date that progressive disease is objectively documented (intracranial or overall according to RANO-BM or RECIST V1.1)
3 years
Phase 2: Intracranial DoR Per Intracranial RECIST V1.1 (iDoR-RECIST)
Time Frame: 3 years
Defined as the duration of time from the date when criteria are met for either a CR or PR per BICR, until the first date that progressive disease is objectively documented (intracranial or overall according to RANO-BM or RECIST V1.1).
3 years
Phase 2: Clinical Benefit Rate (CBR) Per Overall RECIST V1.1 at 16 Weeks (CBR-16w)
Time Frame: 16 weeks
Defined as the proportion of participants who have achieved either a confirmed CR or PR or stable disease (SD) at ≥16 weeks from the first dose per BICR.
16 weeks
Phase 2: Intracranial CBR Per RANO-BM at 16 Weeks (iCBR-RANO-16w)
Time Frame: 16 weeks
Defined as the percentage of participants who have achieved either a confirmed CR or PR or SD at ≥16 weeks from the first dose per BICR.
16 weeks
Phase 2: Intracranial CBR Per Intracranial RECIST V1.1 at 16 Weeks (iCBR-RECIST-16w)
Time Frame: 16 weeks
Defined as the percentage of participants who have achieved either a confirmed CR or PR or SD at ≥16 weeks from the first dose per BICR.
16 weeks
Phase 2: CBR Per Overall RECIST V1.1 at 24 Weeks (CBR-24w)
Time Frame: 24 weeks
Defined as percentage of participants who have achieved either a confirmed CR or PR or SD at ≥24 weeks from the first dose per BICR.
24 weeks
Phase 2: Intracranial CBR Per RANO-BM at 24 Weeks (iCBR-RANO-24w)
Time Frame: 24 weeks
Defined as the percentage of participants who have achieved either a confirmed CR or PR or SD at ≥24 weeks from the first dose per BICR.
24 weeks
Phase 2: Intracranial CBR Per Intracranial RECIST V1.1 at 24 Weeks (iCBR-RECIST-24w)
Time Frame: 24 weeks
Defined as the percentage of participants who have achieved either a confirmed CR or PR or SD at ≥24 weeks from the first dose per BICR.
24 weeks
Phase 2: Progression-Free Survival (PFS)
Time Frame: 3 years
Defined as the length of time from first intake until the date of objective disease progression (intracranial or overall according to RANO-BM or RECIST V1.1) per BICR or death from any cause.
3 years
Phase 2: Intracranial PFS (iPFS)
Time Frame: 3 years
Defined as the length of time from first intake until the date of intracranial objective disease progression (per RANO-BM or intracranial RECIST V 1.1) per BICR or death from any cause.
3 years
Phase 2: OS
Time Frame: 3 years
Defined as the length of time from first intake until the date of death from any cause.
3 years
Phase 2: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time Frame: Baseline up to end of treatment (3 years)
Baseline up to end of treatment (3 years)
Phase 2: Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score
Time Frame: Baseline up to end of treatment (3 years)
Baseline up to end of treatment (3 years)
Phase 2: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain 20 (EORTC QLQ-BN20) Score
Time Frame: Baseline up to end of treatment (3 years)
Baseline up to end of treatment (3 years)
Phase 2: Change From Baseline in Mini-Mental State Examination-2nd edition (MMSE-2) Standard Version (SV) Scale Score
Time Frame: Baseline up to end of treatment (3 years)
Baseline up to end of treatment (3 years)
Phase 2: Change From Baseline in Neurologic Assessment in Neuro-Oncology (NANO) Scale Score
Time Frame: Baseline up to end of treatment (3 years)
Baseline up to end of treatment (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemline Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELA-0121
  • 2024-512878-98-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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