Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05696626
PHASE3

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Sponsor: LeonaBio

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Official title: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-10-31

Completion Date

2028-04

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Lasofoxifene in combination with abemaciclib

5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day

DRUG

Fulvestrant in combination with abemaciclib

Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day

Locations (224)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

University of Arizona - Cancer Center

Tucson, Arizona, United States

Providence Medical Foundation - Santa Rosa, CA

Santa Rosa, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Miami Cancer Institute Plantation

Plantation, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Allina Health System DBA Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Renown Regional Medical Centre

Reno, Nevada, United States

Cancer Care Specialists

Reno, Nevada, United States

New Jersey Cancer Care, PA

Belleville, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, United States

Presbyterian Rust Cancer Center

Rio Rancho, New Mexico, United States

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Altru Health Systems

Grand Forks, North Dakota, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Harris Health System - Smith Clinic

Houston, Texas, United States

Swedish Cancer Institute (SCI)

Seattle, Washington, United States

Blacktown Hospital

Blacktown, Australia

Concord Repatriation General Hospital

Concord, Australia

Mater Misericordiae Ltd, South Brisbane

South Brisbane, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital (UZA)

Edegem, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

CHU UCL Namur - Site De Sainte-Elisabeth

Namur, Belgium

The Ottawa General Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre -Bayview Campus

Toronto, Ontario, Canada

Hospital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Lady Davis Institute for Medical Research Jewish General Hospital

Montreal, Quebec, Canada

CIUSSS du Saguenay-Lac-Saint-Jean

Saguenay, Quebec, Canada

Anhui Provincial Cancer Hospital

Anhui, China

Anyang Tumour Hospital

Anyang, China

Beijing Cancer Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

The First Hospital of Jilin University

Changchun, China

The Second Xiangya Hospital of Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

The First Affiliated Hospital, Chongqing Medical University

Chongqicun, China

The Second Hospital of Dalian Medical University

Dalian, China

Deyang People's Hospital

Deyang, China

Fuyang Cancer Hosptial

Fuyang, China

Fujian Cancer Hospital

Fuzhou, China

Fujian Medical University Union Hospital

Fuzhou, China

Zhujiang Hospital of Nanfang Medical University

Guandong, China

Guangdong Provincial People's Hospital

Guangdong, China

Meizhou People's Hospital

Guangdong, China

Peking University Shenzhen Hospital

Guangdong, China

Sun Yat-Sen University- Cancer Center

Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

The First Affiliated Hospital of Hainan Medical University

Haikou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, China

Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, China

Hebei Medical University - The Fourth Hospital - Hebei Provincial Tumor Hospital

Hebei, China

Xiangyang Central Hospital

Hubei, China

Xiangya Hospital Central South University

Hunan, China

Jieyang People's Hospital

Jieyang, China

Shandong Province Tumor Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Gansu Provincial Hospital

Lanzhou, China

The First Hospital of Lanzhou University

Lanzhou, China

Linyi Cancer Hospital

Linyi, China

Luoyang Central Hospital

Luoyang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The Affiliated Hospital of Southwest Medical University (Luzhou Medical College)

Luzhou, China

Jiangxi Cancer Hospital

Nanchang, China

Nanchang People's Hospital

Nanchang, China

Jiangsu Province Hospital - The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

Nanjing Drum Tower Hospital

Nanjing, China

Guangxi Medical University Cancer Hospital

Nanning, China

Nanyang Central Hospital

Nanyang, China

The Second People's Hospital of Neijiang

Neijiang, China

Ningbo Medical Center Li Huili Hospital

Ningbo, China

The First People'S Hospital of Ping Ding Shan

Pingdingshan, China

Qingdao Central Hospital, University of Health and Rehabilitation Sciences

Qingdao, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Quanzhou First Hospital

Quanzhou, China

Huashan Hospital, Fudan University

Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Fudan University Cancer Center

Shang’ai, China

First Affiliated Hospital of Xi'an Jiaotong University

Shanxi, China

The Central Hospital of Shaoyang

Shaoyang, China

Liaoning Cancer Hospital & Institute

Shenyang, China

Yuebei People's Hospital

Shouguang, China

University of Electonic Science & Technology (UESTC) - Sichuan Cancer Hospital & Institute

Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Hubei Cancer Hospital

Wuhan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technolog

Wuhan, China

The Second People's Hospital of WuHu

Wuhu, China

The First Affiliated Hospital of Air Force Medical University

Xi Ail, China

The first affiliated hospital of Xiamen University

Xiamen, China

Zhongshang Hospital Xiamen University

Xiamen, China

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xinzheng, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Xuzhou Central Hospital

Xuzhou, China

Yuncheng Central Hospital

Yuncheng, China

Zhejiang cancer hospital

Zhejiang, China

Zhejiang Provincial People's Hospital

Zhejiang, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhongshan City People's Hospital

Zhongshan, China

Zhumadian Central Hospital

Zhumadian, China

Institut Sainte Catherine

Avignon, France

Service d'Oncologie Medicale - CHRU Besancon

Besançon, France

Institut Bergonie

Bordeaux, France

Centre Francois Baclesse

Caen, France

Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo

Le Mans, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)

Poitiers, France

Centre Henri Becquerel

Rouen, France

Institut Claudius Regaud

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Klinikum rechts der Isar der Technischen Universitaet Muenchen

München, Germany

Haemek Medical Center

Afula, Israel

Soroka Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Hadassah Ein-Karem Medical Center

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin MC

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Azienda Ospedaliero-Universitaria delle Marche

Ancona, Italy

Centro Riferimento Oncologico - Aviano

Aviano, Italy

La Fondazione e l'Istituto di Candiolo

Candiolo, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

Meldola, Italy

Istituto Europeo di Oncologia

Milan, Italy

Humanitas Istituto Clinico Catanese

Misterbianco, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore Della Carita

Novara, Italy

Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera

Padova, Italy

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

Verona, Italy

KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Biała Podlaska, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, I Klinika Radioterapii i Chemioterapii

Gliwice, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej

Krakow, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym

Krakow, Poland

Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii

Lodz, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii

Poznan, Poland

Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center

Poznan, Poland

Mazowiecki Szpital Onkologiczny

Wieliszew, Poland

Centrul Medical Focus

Bucharest, Romania

Memorial Healthcare International SRL

Bucharest, Romania

Radiotherapy Center Cluj

Cluj-Napoca, Romania

Onco Clinic Consult SA

Craiova, Romania

Oncology Center Sfantul Nectarie

Craiova, Romania

Gral Medical SRL

Piteşti, Romania

OncoMed Oncology Center

Timișoara, Romania

Curie Oncology

Singapore, Singapore

National Cancer Center

Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Beata Maria Ana

Madrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Changhua Christian Hospital (CCH)

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital (CGMHLK)

Taoyuan, Taiwan

Liv Hospital Ankara

Çankaya, Ankara, Turkey (Türkiye)

Istanbul University CAPA Medical Faculty

Çapa, Istanbul, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadiköy, Istanbul, Turkey (Türkiye)

Ege University Medical Faculty Hospital

Bornova, İzmir, Turkey (Türkiye)

Suat Seren Training and Research Hospital

Konak, İzmir, Turkey (Türkiye)

Kocaeli University Research and Application Hospital

İzmit, Kocaeli, Turkey (Türkiye)

Ankara University Medical Faculty Medical Oncology Department

Ankara, Turkey (Türkiye)

Uludag University Faculty of Medicine Hospital

Bursa, Turkey (Türkiye)

Trakya University Medical Faculty Hospital

Edirne, Turkey (Türkiye)

Medical Point Izmir Hospital

Izmir, Turkey (Türkiye)

Velindre Cancer Center

Cardiff, United Kingdom

Princess Alexandra Hospital - Harlow

Harlow, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Milton Keynes Hospital

Milton Keynes, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

University Hospital of North Tees

Stockton-on-Tees, United Kingdom