AzTrials
AzTrials

Breast NeoplasmsPhase 1/2ELECTRANCT05386108

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

A Phase 1/2 study testing Elacestrant and Abemaciclib in people with Breast Neoplasms and Brain Neoplasms, run by Stemline Therapeutics, Inc. at 86 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Elacestrant and Abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
86 sitesin 10 countries
Study dates
31 Aug 2022to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has the signed informed consent form before any study-related activities according to local guidelines.
  • 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:
  • Age ≥60 years
  • 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
  • Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).
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  • 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.
  • 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
  • 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:
  • Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.
  • Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.
  • 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.
  • 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.
  • Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.
  • 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.
  • Participant has documented intracranial and/or extracranial radiological progression or recurrence while on or after the most recent therapy.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Participant has a life expectancy ≥ 12 weeks.
  • Participant has adequate bone marrow and organ function, as defined by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥1.5 × 10^9/liter (L)
  • Platelets ≥100 × 10^9/L
  • Hemoglobin ≥9.0 grams (g)/deciliter (dL)
  • 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)
  • Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL/minute
  • Serum albumin ≥3.0 g/dL (≥30 g/L)
  • 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.
  • 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
  • The participant is willing and able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.
  • Participant has imminent organ failure and/or visceral crisis.
  • 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.
  • Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced/metastatic setting.
  • History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.
  • 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.
  • Major surgery within 4 weeks of starting trial therapy.
  • 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.
  • 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:
  • Intrauterine device (non-hormonal)
  • Sexual abstinence
  • Bilateral tubal occlusion/ligation
  • Have a vasectomized partner with confirmed azoospermia.
  • 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.
  • 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.
  • Known intolerance to either study drug or any of their excipients.
  • Participants currently receiving or received any of the following medications prior to first dose of trial therapy:
  • 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)
  • 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
  • Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.
  • Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.

Trial locations and contacts

86 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Stemline Trials contact

1-877-332-7961

clinicaltrials@menarinistemline.com

86 sites in 10 countries

Italy14 sites, 14 recruiting

  • AOU Ospedali Riuniti Umberto I-G.M.Lancisi -G.Salesi

    Ancona

    Rossana Berardi

    Recruiting

  • INOC - Istituto Nazionale Oncologico Candiolo

    Candiolo

    Diletta Favero

    Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS

    Meldola

    Michela Palleschi

    Recruiting

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

    Messina

    Ricciardi Giuseppina

    Recruiting

  • IEO - Istituto Europeo di Oncologia, IRCCS

    Milan

    Giuseppe Curigliano

    Recruiting

  • Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena

    Modena

    Annalisa Fontana

    Recruiting

  • Ospedale San Gerardo, ASST di Monza, IRCCS

    Monza

    Marina Cazzaniga

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples

    Mario Giuliano

    Recruiting

  • Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS

    Naples

    Michelino De Laurentiis

    Recruiting

  • Istituto Oncologico Veneto IOV - IRCCS

    Padova

    Valentina Guarneri

    Recruiting

  • IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia Fondazione IRCCS Policlinico San Matteo

    Pavia

    Angioletta Lasagna

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Alessandra Fabi

    Recruiting

  • Azienda Ospedaliera Santa Maria di Terni

    Terni

    Jennifer Foglietta

    Recruiting

  • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette

    Torino

    Massimiliano Icardi

    Recruiting

Other trials in Italy

Spain14 sites, 14 recruiting

  • Hospital Clinic De Barcelona

    Barcelona, 08036

    Milana Bergamino

    Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona

    Esther Zamora Adelantado

    Recruiting

  • University Hospital Reina Sofía

    Córdoba, Andalusia, 14004

    Juan Rafael De La Haba Rodriguez

    Recruiting

  • University Clinical Hospital Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    Jose Luis Alonso Romero

    Recruiting

  • University Hospital Ramón y Cajal

    Madrid, Madrid, 28034

    Elena Lopez Miranda

    Recruiting

  • University Hospital 12 de Octubre

    Madrid, Madrid, 28041

    Eva Ciruelos Gil

    Recruiting

  • Clara Campal Comprehensive Cancer Center (CIOCC)

    Madrid, Madrid, 28050

    Raquel Bratos Lorenzo

    Recruiting

  • Clinica Universidad de Navarra

    Madrid

    Marta Santisteban Eslava

    Recruiting

  • Hospital Clínico San Carlos

    Madrid

    José García Sáenz

    Recruiting

  • Hospital Universitario Quirónsalud Madrid

    Madrid

    Jesus Fuentes Antras

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona

    Marta Santisteban Eslava

    Recruiting

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, 15706

    Rafael Lopez Lopez

    Recruiting

  • Fundación Instituto Valenciano De Oncología

    Valencia

    Joaquin Gavilá Gregori

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Valencia

    Manuel Ruiz Borrego

    Recruiting

Other trials in Spain

United States11 sites, 8 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Nancy Lin

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Jhansi Koduri

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Haythem Ali

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Monica Lee

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Nuhad Ibrahim

    Recruiting

  • California Research Institute

    Los Angeles, California, 90027

    Ghassan Al-Jazavrly

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Completed

  • Virginia Cancer Institute

    Norfolk, Virginia, 00115

    Michael Danso

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Completed

  • UT Health San Antonio University of Texas

    San Antonio, Texas, 78229

    Completed

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Kendrith Rowland

    Recruiting

Other trials in United States

Turkey (Türkiye)11 sites, 11 recruiting

  • Adana Sehir Hastanesi

    Adana

    Timucin Cil

    Recruiting

  • Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi

    Ankara

    Mehmet Sendur

    Recruiting

  • Ankara University Medical Faculty

    Ankara

    Yuksel Urun

    Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara

    Cengiz Karacin

    Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

    Ankara

    Nuri Karadurmus

    Recruiting

  • Hacettepe University Medical Faculty

    Ankara

    Sercan Aksoy

    Recruiting

  • Memorial Ankara Hastanesi Tibbi Onkoloji

    Ankara

    Umut Demirci

    Recruiting

  • Ege University Medical Faculty

    Bornova

    Burcu Cakar

    Recruiting

  • Acibadem Altunizade Hospital

    Istanbul

    Gul Basaran

    Recruiting

  • Medipol Mega Hospital - Medical Oncology

    Istanbul

    Ahmet Bilici

    Recruiting

  • Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul

    Mahmut Gumus

    Recruiting

Other trials in Turkey (Türkiye)

France9 sites, 9 recruiting

  • Institut de Cancerologie de l'Ouest site Paul Papin

    Angers

    Paule Augereau

    Recruiting

  • Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie

    Brest

    Laura Deiana

    Recruiting

  • Centre Francois Baclesse - Oncologie Medicale - Cancerolo

    Caen

    George Emile

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Marie-Ange Mouret-Reynier

    Recruiting

  • Centre Léon Bérard - Département Oncologie Médicale

    Lyon

    Louis Larrouquere

    Recruiting

  • Centre de Cancerologie du Grand Montpellier

    Montpellier, 37070

    Cristian Villanueva

    Recruiting

  • Hôpital de la Pitiê Salpêtriêre

    Paris, 75103

    Tichoue Herve Foka

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

    Nicolas Isambert

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31100

    Florence Dalenc

    Recruiting

Other trials in France

Germany9 sites, 8 recruiting

  • Klinikum Bayreuth GmbH

    Bayreuth, 95445

    Christoph Mundhenke

    Recruiting

  • Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde

    Cologne

    Completed

  • Universitatsklinikum Carl Gustav Carus

    Dresden

    Pauline Wimberger

    Recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf

    Tanja Fehm

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen

    Peter Fasching

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Tjoung-Won Park-Simon

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Dirk Forstmeyer

    Recruiting

  • Klinikum Worms gGmbH

    Worms, 67550

    Eva Werner

    Recruiting

  • Helios Klinikum Wuppertal

    Wuppertal

    Vesna Bjelic-Radisic

    Recruiting

Other trials in Germany

South Korea6 sites, 6 recruiting

  • Asan Medical Center

    Seoul, 05505

    Sung-Bae Kim

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Jee Hung Kim

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Ji-Yeon Kim

    Recruiting

  • Ewha Womans University MokDong Hospital

    Seoul, 07985

    Kyoung-Eun Lee

    Recruiting

  • Seoul National University Bundang Hospital

    Seoul

    Jee Hyun Kim

    Recruiting

  • Seoul National University Hospital

    Seoul

    Kyung-Hun Lee

    Recruiting

Other trials in South Korea

United Kingdom5 sites, 3 recruiting

  • University Hospitals of Leicester NHS Trust -Glenfield Hospital

    Leicester

    Withdrawn

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool

    Withdrawn

  • Guy's and St Thomas' NHS Foundation Trust

    London

    Ellie McDowall, 44 207 188 7188 ext. 51783, Ellie.mcdowall@gstt.nhs.uk

    Angela Swampillai

    Recruiting

  • University College London Hospitals NHS Foundation Trust - University College Hospital (UCH) - Macmillan Cancer Centre

    London

    Ioannis Charalampidis, 44 203 447 2929, ioannis.charalampidis@nhs.net

    Elisavet Papadimitraki

    Recruiting

  • The Christie NHS Foundation Trust - Medical Oncology

    Manchester, M20 4BX

    Zoe Brammer, 44 161 446 8347, zoe.brammer@nhs.net

    44 161 918 2352

    Recruiting

Other trials in United Kingdom

Greece4 sites, 2 recruiting

  • National and Capodistrian University of Athens - University General Hospital Attikon

    Athens, 12462

    Completed

  • Metropolitan Hospital [Oncology]

    Piraeus, 12462

    Eleni Linardou

    Recruiting

  • EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki, 54645

    Completed

  • Interbalkan European Medical Center

    Thessaloniki, 57001

    Konstantinos Papazisis

    Recruiting

Other trials in Greece

Belgium3 sites, 3 recruiting

  • Antwerp University Hospital

    Edegem, 2650

    Konstantinos Papadimitriou

    Recruiting

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven

    Patrick Neven

    Recruiting

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert

    Francois Duhoux

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Being tested
Elacestrant, Abemaciclib
Medical subject headings
Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Also called Elacestrant dihydrochloride, RAD-1901, ER-306323, Orserdu

    300 mg, 400 mg

  • AbemaciclibDrug

    Also called Verzenio

    100 mg, 150 mg

Study groups in NCT05386108
Study groupRoleWhat they receive
Phase 1b Cohort 1ExperimentalElacestrant 300 milligrams (mg) once daily (QD) + abemaciclib 100 mg twice daily (BID)
Receives: Drug: Elacestrant; Drug: Abemaciclib
Phase 1b Cohort 2ExperimentalElacestrant 400 mg QD + abemaciclib 100 mg BID
Receives: Drug: Elacestrant; Drug: Abemaciclib
Phase 1b Cohort 3ExperimentalElacestrant 400 mg QD + abemaciclib 150 mg BID
Receives: Drug: Elacestrant; Drug: Abemaciclib
Phase 2ExperimentalElacestrant in combination with abemaciclib at the RP2D determined in Phase 1b
Receives: Drug: Elacestrant; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: RP2D

    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.

    Measured: Cycle 1 (28 days)

  2. Phase 2: Objective Response Rate (ORR) Per Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

    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).

    Measured: 3 years

Secondary outcomes (29)

  1. Phase 1b and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: 3 years

  2. Phase 1b and 2: Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau)

    Measured: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)

  3. Phase 1b and 2: Maximum Observed Plasma Concentration (Cmax)

    Measured: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)

  4. Phase 1b and 2: Time to Reach Cmax (Tmax)

    Measured: Cycle 1 Day 15 (predose and up to 24 hours postdose) (Cycle length = 28 days)

  5. Phase 1b: ORR As Per Local Investigator's Assessment and Per BICR

    Measured: 3 years

  6. Phase 1b: Duration of Response (DoR) As Per Local Investigator's Assessment and Per BICR

    Measured: 3 years

  7. Phase 1b: Clinical Benefit Rate (CBR) at 16 Weeks As Per Local Investigator's Assessment and Per BICR

    Measured: 16 weeks

  8. Phase 1b: CBR at 24 Weeks As Per Local Investigator's Assessment and Per BICR

    Measured: 24 weeks

  9. Phase 1b: Progression-free Survival (PFS) As Per Local Investigator's Assessment and Per BICR

    Measured: 3 years

  10. Phase 1b: Overall Survival (OS)

    Measured: 3 years

  11. Phase 2: Intracranial Objective Response Rate (iORR) per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) (iORR-RANO)

    Defined as the proportion of participants achieving a best overall intracranial response of confirmed PR + CR, based on intracranial lesions.

    Measured: 3 years

  12. Phase 2: iORR Per Intracranial RECIST V1.1 (iORR-RECIST)

    Defined as the proportion of participants achieving a best overall intracranial response of confirmed PR + CR, per BICR.

    Measured: 3 years

  13. Phase 2: DOR Per Overall RECIST V1.1

    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).

    Measured: 3 years

  14. Phase 2: Intracranial DoR Per RANO-BM (iDoR-RANO)

    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)

    Measured: 3 years

  15. Phase 2: Intracranial DoR Per Intracranial RECIST V1.1 (iDoR-RECIST)

    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).

    Measured: 3 years

  16. Phase 2: Clinical Benefit Rate (CBR) Per Overall RECIST V1.1 at 16 Weeks (CBR-16w)

    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.

    Measured: 16 weeks

  17. Phase 2: Intracranial CBR Per RANO-BM at 16 Weeks (iCBR-RANO-16w)

    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.

    Measured: 16 weeks

  18. Phase 2: Intracranial CBR Per Intracranial RECIST V1.1 at 16 Weeks (iCBR-RECIST-16w)

    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.

    Measured: 16 weeks

  19. Phase 2: CBR Per Overall RECIST V1.1 at 24 Weeks (CBR-24w)

    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.

    Measured: 24 weeks

  20. Phase 2: Intracranial CBR Per RANO-BM at 24 Weeks (iCBR-RANO-24w)

    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.

    Measured: 24 weeks

  21. Phase 2: Intracranial CBR Per Intracranial RECIST V1.1 at 24 Weeks (iCBR-RECIST-24w)

    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.

    Measured: 24 weeks

  22. Phase 2: Progression-Free Survival (PFS)

    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.

    Measured: 3 years

  23. Phase 2: Intracranial PFS (iPFS)

    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.

    Measured: 3 years

  24. Phase 2: OS

    Defined as the length of time from first intake until the date of death from any cause.

    Measured: 3 years

  25. Phase 2: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

    Measured: Baseline up to end of treatment (3 years)

  26. Phase 2: Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score

    Measured: Baseline up to end of treatment (3 years)

  27. Phase 2: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain 20 (EORTC QLQ-BN20) Score

    Measured: Baseline up to end of treatment (3 years)

  28. Phase 2: Change From Baseline in Mini-Mental State Examination-2nd edition (MMSE-2) Standard Version (SV) Scale Score

    Measured: Baseline up to end of treatment (3 years)

  29. Phase 2: Change From Baseline in Neurologic Assessment in Neuro-Oncology (NANO) Scale Score

    Measured: Baseline up to end of treatment (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start31 Aug 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386108
Sponsor's protocol ID
ELA-0121
Other IDs
2024-512878-98-00
Acronym
ELECTRA
Status last verified
Oct 2026
First submitted
16 May 2022
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Elacestrant and Abemaciclib in people with Breast Neoplasms and Brain Neoplasms, run by Stemline Therapeutics, Inc. at 86 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Italy, Spain, United States, Turkey (Türkiye), France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stemline Trials (1-877-332-7961, clinicaltrials@menarinistemline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: RP2D (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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