New hope for Hard-to-Treat breast cancer: drug combo targets gene mutation

NCT ID NCT05696626

Recruiting now Disease control Sponsor: LeonaBio Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug combination (lasofoxifene plus abemaciclib) works better than a standard combination (fulvestrant plus abemaciclib) for people with advanced ER+/HER2- breast cancer that has a specific gene change (ESR1 mutation). About 500 adults whose cancer worsened after prior treatment will take pills or receive injections. The goal is to see which combo delays cancer growth longer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

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

METASTATIC BREAST CANCER

Contacts and locations

Locations

Allina Health System DBA Virginia Piper Cancer Institute
RECRUITING

Minneapolis, Minnesota, 55407, United States
Altru Health Systems
COMPLETED

Grand Forks, North Dakota, 58201, United States
Anhui Provincial Cancer Hospital
RECRUITING

Anhui, China
Ankara University Medical Faculty Medical Oncology Department
NOT_YET_RECRUITING

Ankara, Turkey (Türkiye)
Antwerp University Hospital (UZA)
WITHDRAWN

Edegem, Belgium
Anyang Tumour Hospital
RECRUITING

Anyang, China
Asan Medical Center
NOT_YET_RECRUITING

Seoul, South Korea
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
COMPLETED

Verona, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita
NOT_YET_RECRUITING

Novara, 28100, Italy
Azienda Ospedaliero Universitaria di Parma
RECRUITING

Parma, Italy
Azienda Ospedaliero-Universitaria delle Marche
RECRUITING

Ancona, Italy
Azienda Ospedaliero-Universitaria di Modena
RECRUITING

Modena, Italy
Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Beijing Cancer Hospital
RECRUITING

Beijing, China
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Blacktown Hospital
RECRUITING

Blacktown, Australia
CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)
RECRUITING

Poitiers, France
CHU UCL Namur - Site De Sainte-Elisabeth
RECRUITING

Namur, Belgium
CIUSSS du Saguenay-Lac-Saint-Jean
WITHDRAWN

Saguenay, Quebec, Canada
Cancer Care Specialists
RECRUITING

Reno, Nevada, 89511-2250, United States
Cancer and Hematology Centers of Western Michigan
RECRUITING

Grand Rapids, Michigan, 49503, United States
Centre Francois Baclesse
RECRUITING

Caen, France
Centre Henri Becquerel
RECRUITING

Rouen, France
Centre Leon Berard
RECRUITING

Lyon, France
Centre Oscar Lambret
RECRUITING

Lille, France
Centro Riferimento Oncologico - Aviano
RECRUITING

Aviano, Italy
Centrul Medical Focus
WITHDRAWN

Bucharest, Romania
Changhua Christian Hospital (CCH)
RECRUITING

Changhua, Taiwan
Charing Cross Hospital
RECRUITING

London, United Kingdom
Chonnam National University Hwasun Hospital
RECRUITING

Jeollanam-do, 58128, South Korea
Cleveland Clinic
WITHDRAWN

Cleveland, Ohio, 44119, United States
Clinica Universidad de Navarra - Madrid
RECRUITING

Madrid, Spain
Clinica Universidad de Navarra - Pamplona
RECRUITING

Pamplona, Spain
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING

Brussels, Belgium
Concord Repatriation General Hospital
RECRUITING

Concord, Australia
Curie Oncology
RECRUITING

Singapore, 329563, Singapore
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02115, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Deyang People's Hospital
RECRUITING

Deyang, China
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27705, United States
Ege University Medical Faculty Hospital
NOT_YET_RECRUITING

Bornova, İzmir, Turkey (Türkiye)
Emory University School of Medicine
RECRUITING

Atlanta, Georgia, 30322, United States
First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING

Shanxi, China
Fondazione IRCCS Policlinico San Matteo
RECRUITING

Pavia, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITING

Roma, Italy
Fudan University Cancer Center
RECRUITING

Shang’ai, China
Fujian Cancer Hospital
RECRUITING

Fuzhou, China
Fujian Medical University Union Hospital
RECRUITING

Fuzhou, China
Fuyang Cancer Hosptial
RECRUITING

Fuyang, China
Gansu Provincial Hospital
RECRUITING

Lanzhou, China
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING

Kadiköy, Istanbul, Turkey (Türkiye)
Gral Medical SRL
RECRUITING

Piteşti, Romania
Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
RECRUITING

Le Mans, 72015, France
Guangdong Provincial People's Hospital
RECRUITING

Guangdong, China
Guangxi Medical University Cancer Hospital
RECRUITING

Nanning, China
HCL Centre Hospitalier Lyon Sud
RECRUITING

Pierre-Bénite, 69310, France
Hadassah Ein-Karem Medical Center
RECRUITING

Jerusalem, Israel
Haemek Medical Center
RECRUITING

Afula, 1834111, Israel
Harris Health System - Smith Clinic
RECRUITING

Houston, Texas, 77054, United States
Hebei Medical University - The Fourth Hospital - Hebei Provincial Tumor Hospital
RECRUITING

Hebei, China
Henan Cancer Hospital
RECRUITING

Zhengzhou, China
Hospital Beata Maria Ana
RECRUITING

Madrid, Spain
Hospital Clinic Barcelona
RECRUITING

Barcelona, Spain
Hospital Fundacion Jimenez Diaz
RECRUITING

Madrid, 28040, Spain
Hospital General Universitario Gregorio Maranon
RECRUITING

Madrid, Spain
Hospital Maisonneuve-Rosemont
RECRUITING

Montreal, Quebec, Canada
Hospital Regional Universitario de Malaga
RECRUITING

Málaga, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital Universitario Ramon y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario Reina Sofia
RECRUITING

Córdoba, Spain
Hospital Universitario Vall d'Hebron
RECRUITING

Barcelona, Spain
Hospital Universitario de La Princesa
RECRUITING

Madrid, Spain
Huashan Hospital, Fudan University
RECRUITING

Shanghai, China
Hubei Cancer Hospital
RECRUITING

Wuhan, China
Humanitas Istituto Clinico Catanese
RECRUITING

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

Meldola, Italy
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Institut Bergonie
RECRUITING

Bordeaux, France
Institut Claudius Regaud
RECRUITING

Toulouse, France
Institut Gustave Roussy
NOT_YET_RECRUITING

Villejuif, 94800, France
Institut Paoli-Calmettes
RECRUITING

Marseille, France
Institut Sainte Catherine
RECRUITING

Avignon, 84000, France
Instituto Valenciano de Oncologia
RECRUITING

Valencia, Spain
Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii
COMPLETED

Lodz, Poland
Istanbul University CAPA Medical Faculty
NOT_YET_RECRUITING

Çapa, Istanbul, Turkey (Türkiye)
Istituto Europeo di Oncologia
RECRUITING

Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING

Naples, Italy
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
NOT_YET_RECRUITING

Padova, 35128, Italy
Jiangsu Province Hospital - The First Affiliated Hospital with Nanjing Medical University
RECRUITING

Nanjing, China
Jiangxi Cancer Hospital
RECRUITING

Nanchang, China
Jieyang People's Hospital
RECRUITING

Jieyang, China
Johns Hopkins Kimmel Cancer Center
RECRUITING

Baltimore, Maryland, 21231, United States
KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
WITHDRAWN

Biała Podlaska, Poland
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
RECRUITING

Kaohsiung City, Taiwan
Kaplan Medical Center
RECRUITING

Rehovot, Israel
Klinikum rechts der Isar der Technischen Universitaet Muenchen
RECRUITING

München, Germany
Kocaeli University Research and Application Hospital
NOT_YET_RECRUITING

İzmit, Kocaeli, Turkey (Türkiye)
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING

Taipei, Taiwan
Korea University Anam Hospital
RECRUITING

Seoul, South Korea
La Fondazione e l'Istituto di Candiolo
RECRUITING

Candiolo, 10060, Italy
Lady Davis Institute for Medical Research Jewish General Hospital
RECRUITING

Montreal, Quebec, Canada
Leeds Teaching Hospitals NHS Trust
RECRUITING

Leeds, United Kingdom
Liaoning Cancer Hospital & Institute
RECRUITING

Shenyang, China
Linkou Chang Gung Memorial Hospital (CGMHLK)
RECRUITING

Taoyuan City, Taiwan
Linyi Cancer Hospital
RECRUITING

Linyi, China
Liv Hospital Ankara
RECRUITING

Çankaya, Ankara, Turkey (Türkiye)
Luoyang Central Hospital
RECRUITING

Luoyang, China
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mater Misericordiae Ltd, South Brisbane
RECRUITING

South Brisbane, Australia
Mayo Clinic - Jacksonville
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic - Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic - Scottsdale
RECRUITING

Scottsdale, Arizona, 85259, United States
Mazowiecki Szpital Onkologiczny
RECRUITING

Wieliszew, Poland
Medical Point Izmir Hospital
NOT_YET_RECRUITING

Izmir, Turkey (Türkiye)
Meir Medical Center
RECRUITING

Kfar Saba, 4428164, Israel
Meizhou People's Hospital
RECRUITING

Guangdong, China
Memorial Healthcare International SRL
NOT_YET_RECRUITING

Bucharest, Romania
Miami Cancer Institute
RECRUITING

Miami, Florida, 33143, United States
Miami Cancer Institute Plantation
RECRUITING

Plantation, Florida, 33324, United States
Milton Keynes Hospital
RECRUITING

Milton Keynes, MK6 5LD, United Kingdom
Nanchang People's Hospital
RECRUITING

Nanchang, China
Nanjing Drum Tower Hospital
RECRUITING

Nanjing, China
Nanyang Central Hospital
RECRUITING

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

Gliwice, Poland
National Cancer Center
RECRUITING

Gyeonggi-do, South Korea
National Cheng Kung University Hospital
RECRUITING

Tainan, Taiwan
National Taiwan University Hospital
RECRUITING

Taipei, Taiwan
New Jersey Cancer Care, PA
WITHDRAWN

Belleville, New Jersey, 07109, United States
Ningbo Medical Center Li Huili Hospital
RECRUITING

Ningbo, China
Norton Cancer Institute
RECRUITING

Louisville, Kentucky, 40202, United States
Nottingham City Hospital
RECRUITING

Nottingham, United Kingdom
Onco Clinic Consult SA
COMPLETED

Craiova, Romania
OncoMed Oncology Center
RECRUITING

Timișoara, Romania
Oncology Center Sfantul Nectarie
RECRUITING

Craiova, Romania
Peking Union Medical College Hospital
RECRUITING

Beijing, China
Peking University Shenzhen Hospital
RECRUITING

Guangdong, China
Presbyterian Kaseman Hospital
NOT_YET_RECRUITING

Albuquerque, New Mexico, 87110, United States
Presbyterian Rust Cancer Center
RECRUITING

Rio Rancho, New Mexico, 87124, United States
Princess Alexandra Hospital - Harlow
RECRUITING

Harlow, CM20 1QX, United Kingdom
Providence Medical Foundation - Santa Rosa, CA
RECRUITING

Santa Rosa, California, 95403, United States
Qingdao Central Hospital, University of Health and Rehabilitation Sciences
RECRUITING

Qingdao, China
Quanzhou First Hospital
RECRUITING

Quanzhou, China
Rabin MC
RECRUITING

Petah Tikva, Israel
Radiotherapy Center Cluj
RECRUITING

Cluj-Napoca, Romania
Rambam Health Care Campus
RECRUITING

Haifa, Israel
Renown Regional Medical Centre
RECRUITING

Reno, Nevada, 89502, United States
Royal Free London NHS Foundation Trust
RECRUITING

London, NW3 2, United Kingdom
Rutgers Cancer Institute of New Jersey
RECRUITING

New Brunswick, New Jersey, 08901, United States
SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej
RECRUITING

Krakow, Poland
Saint Luke's Cancer Institute
RECRUITING

Kansas City, Missouri, 64111, United States
Service d'Oncologie Medicale - CHRU Besancon
RECRUITING

Besançon, France
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING

Seoul, South Korea
Shaare Zedek Medical Center
RECRUITING

Jerusalem, Israel
Shandong Province Tumor Hospital
RECRUITING

Jinan, China
Sheba Medical Center
RECRUITING

Tel Litwinsky, Israel
Sichuan Provincial People's Hospital
RECRUITING

Chengdu, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING

Hangzhou, China
Soroka Medical Center
RECRUITING

Beersheba, 8486614, Israel
Suat Seren Training and Research Hospital
NOT_YET_RECRUITING

Konak, İzmir, Turkey (Türkiye)
Sun Yat-Sen University- Cancer Center
RECRUITING

Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING

Guangzhou, China
Sunnybrook Health Sciences Centre -Bayview Campus
RECRUITING

Toronto, Ontario, Canada
Swedish Cancer Institute (SCI)
WITHDRAWN

Seattle, Washington, 98104, United States
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym
RECRUITING

Krakow, Poland
Tel Aviv Sourasky Medical Center
RECRUITING

Tel Aviv, Israel
The Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING

Ürümqi, China
The Affiliated Hospital of Qingdao University
RECRUITING

Qingdao, China
The Affiliated Hospital of Southwest Medical University (Luzhou Medical College)
RECRUITING

Luzhou, China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING

Xuzhou, China
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
RECRUITING

New York, New York, 10011, United States
The Central Hospital of Shaoyang
RECRUITING

Shaoyang, China
The Christie NHS Foundation Trust
RECRUITING

Manchester, United Kingdom
The First Affiliated Hospital of Air Force Medical University
RECRUITING

Xi Ail, China
The First Affiliated Hospital of Bengbu Medical University
RECRUITING

Bengbu, China
The First Affiliated Hospital of Hainan Medical University
RECRUITING

Haikou, China
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING

Luoyang, China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, China
The First Affiliated Hospital of Zhengzhou University
RECRUITING

Zhengzhou, China
The First Affiliated Hospital, Chongqing Medical University
RECRUITING

Chongqicun, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING

Hangzhou, China
The First Hospital of Jilin University
RECRUITING

Changchun, China
The First Hospital of Lanzhou University
RECRUITING

Lanzhou, China
The First People'S Hospital of Ping Ding Shan
RECRUITING

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

Columbus, Ohio, 42112, United States
The Ottawa General Hospital
RECRUITING

Ottawa, Ontario, Canada
The Second Affiliated Hospital Of Xi'an Jiaotong University
RECRUITING

Xinzheng, China
The Second Hospital of Dalian Medical University
RECRUITING

Dalian, China
The Second People's Hospital of Neijiang
RECRUITING

Neijiang, China
The Second People's Hospital of WuHu
RECRUITING

Wuhu, China
The Second Xiangya Hospital of Central South University
RECRUITING

Changsha, China
The first affiliated hospital of Xiamen University
RECRUITING

Xiamen, China
Tianjin Cancer Hospital Airport Hospital
RECRUITING

Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, China
Trakya University Medical Faculty Hospital
NOT_YET_RECRUITING

Edirne, Turkey (Türkiye)
Tri-Service General Hospital
RECRUITING

Taipei, Taiwan
Uludag University Faculty of Medicine Hospital
NOT_YET_RECRUITING

Bursa, Turkey (Türkiye)
Union Hospital Tongji Medical College Huazhong University of Science and Technolog
RECRUITING

Wuhan, China
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING

Dresden, Germany
Universitaire Ziekenhuizen Leuven
RECRUITING

Leuven, Belgium
University Hospital of North Tees
WITHDRAWN

Stockton-on-Tees, TS198PE, United Kingdom
University Hospitals Seidman Cancer Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of Arizona - Cancer Center
RECRUITING

Tucson, Arizona, 85719, United States
University of Electonic Science & Technology (UESTC) - Sichuan Cancer Hospital & Institute
RECRUITING

Sichuan, China
University of Pittsburgh Medical Center
COMPLETED

Pittsburgh, Pennsylvania, 15232, United States
Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii
RECRUITING

Poznan, Poland
Velindre Cancer Center
NOT_YET_RECRUITING

Cardiff, CF14 2TL, United Kingdom
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West China Hospital, Sichuan University
RECRUITING

Chengdu, China
Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center
RECRUITING

Poznan, Poland
Xiangya Hospital Central South University
RECRUITING

Hunan, China
Xiangyang Central Hospital
RECRUITING

Hubei, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING

Shanghai, China
Xuzhou Central Hospital
RECRUITING

Xuzhou, China
Yuebei People's Hospital
RECRUITING

Shouguang, China
Yuncheng Central Hospital
RECRUITING

Yuncheng, China
Yunnan Cancer Hospital
RECRUITING

Kunming, China
Zhejiang Provincial Hospital of Chinese Medicine
RECRUITING

Hangzhou, China
Zhejiang Provincial People's Hospital
RECRUITING

Zhejiang, China
Zhejiang cancer hospital
RECRUITING

Zhejiang, China
Zhongshan City People's Hospital
RECRUITING

Zhongshan, China
Zhongshang Hospital Xiamen University
RECRUITING

Xiamen, China
Zhujiang Hospital of Nanfang Medical University
RECRUITING

Guandong, China
Zhumadian Central Hospital
RECRUITING

Zhumadian, China

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