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

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2028

Conditions
Metastatic Breast Cancer
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

Trial Locations (220)

10011

RECRUITING

The Blavatnik Family - Chelsea Medical Center at Mount Sinai, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10060

NOT_YET_RECRUITING

La Fondazione e l'Istituto di Candiolo, Candiolo

10065

RECRUITING

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

15232

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

21231

RECRUITING

Johns Hopkins Kimmel Cancer Center, Baltimore

27705

RECRUITING

Duke University Medical Center, Durham

28034

NOT_YET_RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28040

NOT_YET_RECRUITING

Hospital Fundacion Jimenez Diaz, Madrid

28100

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Maggiore Della Carita, Novara

30322

RECRUITING

Emory University School of Medicine, Atlanta

32224

RECRUITING

Mayo Clinic - Jacksonville, Jacksonville

33143

RECRUITING

Miami Cancer Institute, Miami

33324

RECRUITING

Miami Cancer Institute Plantation, Plantation

35128

NOT_YET_RECRUITING

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

40202

RECRUITING

Norton Cancer Institute, Louisville

42112

RECRUITING

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

44106

NOT_YET_RECRUITING

University Hospitals Seidman Cancer Center, Cleveland

49503

RECRUITING

Cancer and Hematology Centers of Western Michigan, Grand Rapids

55407

RECRUITING

Allina Health System DBA Virginia Piper Cancer Institute, Minneapolis

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

58201

RECRUITING

Altru Health Systems, Grand Forks

63110

RECRUITING

Washington University School of Medicine, St Louis

64111

RECRUITING

Saint Luke's Cancer Institute, Kansas City

69310

NOT_YET_RECRUITING

HCL Centre Hospitalier Lyon Sud, Pierre-Bénite

72015

NOT_YET_RECRUITING

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

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

MD Anderson Cancer Center, Houston

77054

RECRUITING

Harris Health System - Smith Clinic, Houston

84000

NOT_YET_RECRUITING

Institut Sainte Catherine, Avignon

85259

RECRUITING

Mayo Clinic - Scottsdale, Scottsdale

85719

RECRUITING

University of Arizona - Cancer Center, Tucson

87124

RECRUITING

Presbyterian Rust Cancer Center, Rio Rancho

89502

RECRUITING

Renown Regional Medical Centre, Reno

94800

NOT_YET_RECRUITING

Institut Gustave Roussy, Villejuif

95403

RECRUITING

Providence Medical Foundation - Santa Rosa, CA, Santa Rosa

98104

NOT_YET_RECRUITING

Swedish Cancer Institute (SCI), Seattle

329563

NOT_YET_RECRUITING

Curie Oncology, Singapore

1834111

NOT_YET_RECRUITING

Haemek Medical Center, Afula

4428164

NOT_YET_RECRUITING

Meir Medical Center, Kfar Saba

8486614

NOT_YET_RECRUITING

Soroka Medical Center, Beersheba

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Dana-Farber Cancer Institute, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

89511-2250

RECRUITING

Cancer Care Specialists, Reno

07109

NOT_YET_RECRUITING

New Jersey Cancer Care, PA, Belleville

08901

NOT_YET_RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

Unknown

RECRUITING

Blacktown Hospital, Blacktown

RECRUITING

Concord Repatriation General Hospital, Concord

RECRUITING

Mater Misericordiae Ltd, South Brisbane, South Brisbane

NOT_YET_RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

NOT_YET_RECRUITING

Antwerp University Hospital (UZA), Edegem

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

RECRUITING

CHU UCL Namur - Site De Sainte-Elisabeth, Namur

RECRUITING

The Ottawa General Hospital, Ottawa

RECRUITING

Sunnybrook Health Sciences Centre -Bayview Campus, Toronto

RECRUITING

Hospital Maisonneuve-Rosemont, Montreal

RECRUITING

Lady Davis Institute for Medical Research Jewish General Hospital, Montreal

WITHDRAWN

CIUSSS du Saguenay-Lac-Saint-Jean, Saguenay

RECRUITING

Anhui Provincial Cancer Hospital, Anhui

NOT_YET_RECRUITING

Anyang Tumour Hospital, Anyang

RECRUITING

Beijing Cancer Hospital, Beijing

NOT_YET_RECRUITING

Peking Union Medical College Hospital, Beijing

RECRUITING

The First Affiliated Hospital of Bengbu Medical University, Bengbu

RECRUITING

The First Hospital of Jilin University, Changchun

RECRUITING

The Second Xiangya Hospital of Central South University, Changsha

RECRUITING

Sichuan Provincial People's Hospital, Chengdu

RECRUITING

West China Hospital, Sichuan University, Chengdu

RECRUITING

The First Affiliated Hospital, Chongqing Medical University, Chongqicun

RECRUITING

The Second Hospital of Dalian Medical University, Dalian

RECRUITING

Deyang People's Hospital, Deyang

RECRUITING

Fuyang Cancer Hosptial, Fuyang

RECRUITING

Fujian Cancer Hospital, Fuzhou

RECRUITING

Fujian Medical University Union Hospital, Fuzhou

RECRUITING

Zhujiang Hospital of Nanfang Medical University, Guandong

RECRUITING

Guangdong Provincial People's Hospital, Guangdong

RECRUITING

Meizhou People's Hospital, Guangdong

RECRUITING

Peking University Shenzhen Hospital, Guangdong

RECRUITING

Sun Yat-Sen University- Cancer Center, Guangdong

RECRUITING

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

RECRUITING

The First Affiliated Hospital of Hainan Medical University, Haikou

RECRUITING

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

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

RECRUITING

Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou

RECRUITING

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

RECRUITING

Xiangyang Central Hospital, Hubei

RECRUITING

Xiangya Hospital Central South University, Hunan

NOT_YET_RECRUITING

Jieyang People's Hospital, Jieyang

RECRUITING

Shandong Province Tumor Hospital, Jinan

NOT_YET_RECRUITING

Yunnan Cancer Hospital, Kunming

RECRUITING

Gansu Provincial Hospital, Lanzhou

RECRUITING

The First Hospital of Lanzhou University, Lanzhou

RECRUITING

Linyi Cancer Hospital, Linyi

NOT_YET_RECRUITING

Luoyang Central Hospital, Luoyang

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

RECRUITING

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

RECRUITING

Jiangxi Cancer Hospital, Nanchang

RECRUITING

Nangchang People's Hospital, Nanchang

NOT_YET_RECRUITING

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

RECRUITING

Nanjing Drum Tower Hospital, Nanjing

RECRUITING

Guangxi Medical University Cancer Hospital, Nanning

RECRUITING

Nanyang Central Hospital, Nanyang

RECRUITING

The Second People's Hospital of Neijiang, Neijiang

RECRUITING

Ningbo Medical Center Li Huili Hospital, Ningbo

NOT_YET_RECRUITING

The First People'S Hospital of Ping Ding Shan, Pingdingshan

RECRUITING

Qingdao Central Hospital, University of Health and Rehabilitation Sciences, Qingdao

RECRUITING

The Affiliated Hospital of Qingdao University, Qingdao

NOT_YET_RECRUITING

Quanzhou First Hospital, Quanzhou

NOT_YET_RECRUITING

Huashan Hospital, Fudan University, Shanghai

RECRUITING

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

RECRUITING

Fudan University Cancer Center, Shang’ai

RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University, Shanxi

RECRUITING

The Central Hospital of Shaoyang, Shaoyang

RECRUITING

Liaoning Cancer Hospital & Institute, Shenyang

RECRUITING

Yuebei People's Hospital, Shouguang

RECRUITING

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

RECRUITING

Tianjin Cancer Hospital Airport Hospital, Tianjin

RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

RECRUITING

Hubei Cancer Hospital, Wuhan

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technolog, Wuhan

NOT_YET_RECRUITING

The Second People's Hospital of WuHu, Wuhu

RECRUITING

The First Affiliated Hospital of Air Force Medical University, Xi Ail

RECRUITING

The first affiliated hospital of Xiamen University, Xiamen

RECRUITING

Zhongshang Hospital Xiamen University, Xiamen

NOT_YET_RECRUITING

The Second Affiliated Hospital Of Xi'an Jiaotong University, Xinzheng

NOT_YET_RECRUITING

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

RECRUITING

Xuzhou Central Hospital, Xuzhou

RECRUITING

Yuncheng Central Hospital, Yuncheng

RECRUITING

Zhejiang cancer hospital, Zhejiang

RECRUITING

Zhejiang Provincial People's Hospital, Zhejiang

RECRUITING

Henan Cancer Hospital, Zhengzhou

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

RECRUITING

Zhongshan City People's Hospital, Zhongshan

RECRUITING

Zhumadian Central Hospital, Zhumadian

RECRUITING

Service d'Oncologie Medicale - CHRU Besancon, Besançon

RECRUITING

Institut Bergonie, Bordeaux

RECRUITING

Centre Francois Baclesse, Caen

RECRUITING

Centre Oscar Lambret, Lille

RECRUITING

Centre Leon Berard, Lyon

RECRUITING

Institut Paoli-Calmettes, Marseille

RECRUITING

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

RECRUITING

Centre Henri Becquerel, Rouen

RECRUITING

Institut Claudius Regaud, Toulouse

NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden, Dresden

NOT_YET_RECRUITING

Klinikum rechts der Isar der Technischen Universitaet Muenchen, München

RECRUITING

Rambam Health Care Campus, Haifa

RECRUITING

Hadassah Ein-Karem Medical Center, Jerusalem

RECRUITING

Shaare Zedek Medical Center, Jerusalem

RECRUITING

Rabin MC, Petah Tikva

RECRUITING

Kaplan Medical Center, Rehovot

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

RECRUITING

Sheba Medical Center, Tel Litwinsky

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria delle Marche, Ancona

RECRUITING

Centro Riferimento Oncologico - Aviano, Aviano

RECRUITING

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

RECRUITING

Istituto Europeo di Oncologia, Milan

RECRUITING

Humanitas Istituto Clinico Catanese, Misterbianco

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria di Modena, Modena

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria di Parma, Parma

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

RECRUITING

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

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento, Verona

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej, Krakow

RECRUITING

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

RECRUITING

Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii, Lodz

NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii, Poznan

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Mazowiecki Szpital Onkologiczny, Wieliszew

NOT_YET_RECRUITING

Centrul Medical Focus, Bucharest

RECRUITING

Radiotherapy Center Cluj, Cluj-Napoca

RECRUITING

Onco Clinic Consult SA, Craiova

RECRUITING

Oncology Center Sfantul Nectarie, Craiova

RECRUITING

Gral Medical SRL, Piteşti

RECRUITING

OncoMed Oncology Center, Timișoara

NOT_YET_RECRUITING

National Cancer Center, Gyeonggi-do

NOT_YET_RECRUITING

Asan Medical Center, Seoul

RECRUITING

Korea University Anam Hospital, Seoul

NOT_YET_RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

RECRUITING

Hospital Clinic Barcelona, Barcelona

RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

RECRUITING

Clinica Universidad de Navarra - Madrid, Madrid

RECRUITING

Hospital Beata Maria Ana, Madrid

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Hospital Universitario de La Princesa, Madrid

RECRUITING

Hospital Regional Universitario de Malaga, Málaga

RECRUITING

Clinica Universidad de Navarra - Pamplona, Pamplona

RECRUITING

Instituto Valenciano de Oncologia, Valencia

RECRUITING

Changhua Christian Hospital (CCH), Changhua

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Kaohsiung City

RECRUITING

National Cheng Kung University Hospital, Tainan City

RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Tri-Service General Hospital, Taipei

RECRUITING

Linkou Chang Gung Memorial Hospital (CGMHLK), Taoyuan

NOT_YET_RECRUITING

Liv Hospital Ankara, Çankaya

NOT_YET_RECRUITING

Istanbul University CAPA Medical Faculty, Çapa

NOT_YET_RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Kadiköy

NOT_YET_RECRUITING

Ege University Medical Faculty Hospital, Bornova

NOT_YET_RECRUITING

Suat Seren Training and Research Hospital, Konak

NOT_YET_RECRUITING

Kocaeli University Research and Application Hospital, İzmit

NOT_YET_RECRUITING

Ankara University Medical Faculty Medical Oncology Department, Ankara

NOT_YET_RECRUITING

Uludag University Faculty of Medicine Hospital, Bursa

NOT_YET_RECRUITING

Trakya University Medical Faculty Hospital, Edirne

NOT_YET_RECRUITING

Medical Point Izmir Hospital, Izmir

RECRUITING

Leeds Teaching Hospitals NHS Trust, Leeds

RECRUITING

Charing Cross Hospital, London

RECRUITING

The Christie NHS Foundation Trust, Manchester

NOT_YET_RECRUITING

Nottingham City Hospital, Nottingham

CF14 2TL

NOT_YET_RECRUITING

Velindre Cancer Center, Cardiff

CM20 1QX

NOT_YET_RECRUITING

Princess Alexandra Hospital - Harlow, Harlow

NW3 2

NOT_YET_RECRUITING

Royal Free London NHS Foundation Trust, London

MK6 5LD

NOT_YET_RECRUITING

Milton Keynes Hospital, Milton Keynes

All Listed Sponsors
lead

Sermonix Pharmaceuticals Inc.

INDUSTRY

NCT05696626 - 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 | Biotech Hunter | Biotech Hunter