RecruitingPhase 1Phase 2NCT05386108

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

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

Sponsor

Stemline Therapeutics, Inc.

Enrollment

73 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Breast Diseases Neoplasms Brain Neoplasms Neoplasms by Site Central Nervous System Neoplasms Brain Diseases Central Nervous System Diseases

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two targeted drugs — abemaciclib (a pill that slows cancer cell division) and elacestrant (a newer hormone-blocking pill) — can help people with advanced hormone-sensitive, HER2-negative breast cancer, particularly when the cancer carries a specific mutation in the ESR1 gene that causes resistance to standard hormone therapy. **You may be eligible if...** - You are 18 or older - You have advanced (metastatic or inoperable) breast cancer that is hormone receptor-positive (HR+) and HER2-negative - Your cancer has been found to carry an ESR1 mutation on a blood or tumor test - You have previously received at least one hormone therapy and a CDK4/6 inhibitor **You may NOT be eligible if...** - You urgently need treatment to prevent organ failure (visceral crisis) - You need immediate treatment for brain metastases - You have already received drugs in the same class as those being studied - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElacestrant

300 mg, 400 mg

DRUGAbemaciclib

100 mg, 150 mg

Locations(86)

Providence Medical Foundation

Fullerton, California, United States

California Research Institute

Los Angeles, California, United States

Carle Cancer Center

Urbana, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

UT Health San Antonio University of Texas

San Antonio, Texas, United States

Virginia Cancer Institute

Norfolk, Virginia, United States

Antwerp University Hospital

Edegem, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

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

Woluwe-Saint-Lambert, Belgium

Institut de Cancerologie de l'Ouest site Paul Papin

Angers, France

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

Brest, France

Centre Francois Baclesse - Oncologie Medicale - Cancerolo

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Léon Bérard - Département Oncologie Médicale

Lyon, France

Centre de Cancerologie du Grand Montpellier

Montpellier, France

Hôpital de la Pitiê Salpêtriêre

Paris, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Institut Claudius Regaud

Toulouse, France

Klinikum Bayreuth GmbH

Bayreuth, Germany

Uniklinik Koeln - Klinik und Poliklinik fuer Frauenheilkunde

Cologne, Germany

Universitatsklinikum Carl Gustav Carus

Dresden, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Klinikum Worms gGmbH

Worms, Germany

Helios Klinikum Wuppertal

Wuppertal, Germany

National and Capodistrian University of Athens - University General Hospital Attikon

Athens, Greece

Metropolitan Hospital [Oncology]

Piraeus, Greece

EUROMEDICA General Clinic of Thessaloniki

Thessaloniki, Greece

Interbalkan European Medical Center

Thessaloniki, Greece

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

Ancona, Italy

Istituto di Candiolo, IRCCS

Candiolo, Italy

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

Meldola, Italy

A. O. Ospedali Riuniti Parpardo, Piemonte, Messina

Messina, Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena

Modena, Italy

Ospedale San Gerardo, ASST di Monza, IRCCS

Monza, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS

Naples, Italy

Istituto Oncologico Veneto IOV - IRCCS

Padova, Italy

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

Pavia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Italy

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

Torino, Italy

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Ewha Womans University MokDong Hospital

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

University Hospital Reina Sofía

Córdoba, Andalusia, Spain

University Hospital Ramón y Cajal

Madrid, Madrid, Spain

University Hospital 12 de Octubre

Madrid, Madrid, Spain

Clara Campal Comprehensive Cancer Center (CIOCC)

Madrid, Madrid, Spain

University Clinical Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Clinic De Barcelona

Barcelona, Spain

Hospital Universitari Vall D Hebron

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complexo Hospitalario Universitario De Santiago

Santiago de Compostela, Spain

Fundación Instituto Valenciano De Oncología

Valencia, Spain

Hospital Universitario Virgen del Rocío

Valencia, Spain

Adana Sehir Hastanesi

Adana, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi Tibbi Onkoloji

Ankara, Turkey (Türkiye)

Ege University Medical Faculty

Bornova, Turkey (Türkiye)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Medipol Mega Hospital - Medical Oncology

Istanbul, Turkey (Türkiye)

Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

University Hospitals of Leicester NHS Trust -Glenfield Hospital

Leicester, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

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

London, United Kingdom

The Christie NHS Foundation Trust - Medical Oncology

Manchester, United Kingdom

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NCT05386108

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