AzTrials
AzTrials

Metastatic Breast CancerPhase 3ELAINEIIINCT05696626

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

A Phase 3 study testing Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib in people with Metastatic Breast Cancer, run by LeonaBio at 224 sites in 17 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
224 sitesin 17 countries
Study dates
31 Oct 2023to Apr 2028
Phase
Phase 3
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

  • Pre- or postmenopausal women or men.
  • Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease.
  • Histological or cytological confirmation of ER+/HER2 - disease
  • No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.
  • At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue.
  • Locally advanced or metastatic breast cancer with at least 1 measurable (according to RECIST 1.1) lesion with or without non-measurable lesions.
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  • Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Adequate organ function
  • Able to swallow tablets
  • Brain metastases are allowed only if the following 4 parameters hold:
  • Asymptomatic,
  • Definitively treated (e.g., radiotherapy, surgery),
  • Not requiring steroids up to 4 weeks before study treatment initiation, AND
  • Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI).
  • Able to understand and voluntarily sign a written informed consent before any screening procedures.
  • Every attempt should be made to obtain a biopsy of metastatic breast cancer tissue, when safe and feasible, to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is done, it may undergo genomic testing at some point to assess for ESR1 mutations and correlation with ctDNA results. If a biopsy is not possible or inappropriate from a clinical standpoint, the ER and HER2 status from the subject's most recent biopsy must confirm that the subject is ER+ and HER2

Who cannot join

  • Lymphangitic carcinomatosis involving the lung.
  • History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
  • Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
  • Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
  • Subjects with a known hypersensitivity to fulvestrant or to any of the excipients
  • Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1).
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  • Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)
  • History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of >480 msec.
  • History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia, unless the event occurred greater than 6 months prior to screening and the subject is treated with chronic anticoagulant therapy such as apixaban (Eliquis) or rivaroxaban (Xarelto).
  • Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure [CHF] or prolonged immobilization).
  • On concomitant strong CYP3A4 inhibitors.
  • On strong and moderate CYP3A4 inducers.
  • Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.
  • Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment).
  • Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  • History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.
  • Positive serum pregnancy test (only if premenopausal).
  • Sexually active premenopausal women and men unwilling to use double-barrier contraception.
  • Women who are breast feeding
  • History of non-compliance to medical regimens.
  • Unwilling or unable to comply with the protocol.
  • Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
  • Subjects with a history of familial hypertriglyceridemia or fasting triglyceride levels >880 mg/dL at screening.
  • Fasting triglyceride level >300 mg/dL and ≤880 mg/dL at screening. Subjects may be retested and enrolled if they have a repeat fasting triglyceride level less than or equal to 300 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).
  • Fasting cholesterol level >400 mg/dL at screening. Subjects may be retested and enrolled if they have a repeat fasting cholesterol level less than or equal to 400 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).

Trial locations and contacts

224 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Simon Daggett - Senior Vice President, Clinical Operations contact

(909) 374-3793 ext. (425) 620-8772

clinicaltrials@leonabio.com

224 sites in 17 countries

China77 sites, 77 recruiting

  • Anhui Provincial Cancer Hospital

    Anhui

    Yueyin Pan, 13805695536, yueyinpan1965@126.com

    Recruiting

  • Anyang Tumour Hospital

    Anyang

    Junlan Guo, fanyuguo201@163.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Huiping Li, 86 13811012595, huipingli2012@hotmail.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Hongyan Ying, 15901226215, yhypumch@163.com

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Jinhai Zhu, 13956331545, bbmczhu@163.com

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Dong Song, 13943189777, songdong117@126.com

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Wenjun Yi, 18608403318, Yiwenjun@csu.edu.cn

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Jing Luo, 18981838521, 42635967@qq.com

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Ting Luo, 18602866299, luoting@wchscu.cn

    Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqicun

    Lu Gan, 18602320222, 914012118@qq.com

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian

    Man Li, 17709873580, dyeyliman@sohu.com

    Recruiting

  • Deyang People's Hospital

    Deyang

    Ying Yi, 8618908103891, 23411004@qq.com

    Recruiting

  • Fuyang Cancer Hosptial

    Fuyang

    Hesheng Qian, 13956814015, qianhesheng@sohu.com

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Yi Zeng, 13905916886, zengyifc@126.com

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou

    Xiaoyan Lin, 13365910793, xiaoyanlin@yahoo.com

    Recruiting

  • Zhujiang Hospital of Nanfang Medical University

    Guandong

    Guangyu Yao, 18675835626, ygy531@163.com

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangdong

    Kun Wang, 13922118086, gzwangkun@126.com

    Recruiting

  • Meizhou People's Hospital

    Guangdong

    Jingna Wu, 13431819838, wujingna@mzrmyy.com

    Recruiting

  • Peking University Shenzhen Hospital

    Guangdong

    Xiaoling Liu

    Recruiting

  • Sun Yat-Sen University- Cancer Center

    Guangdong

    Shusen Wang, 13926168469, Wangshusench@yahoo.com.cn

    Recruiting

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

    Guangzhou

    Yaping Yang, 13602409759, yypapple1225@163.com

    Recruiting

  • The First Affiliated Hospital of Hainan Medical University

    Haikou

    Jinsheng Wu, 13707599070, wjs7911@126.com

    Recruiting

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

    Hangzhou

    Xian Wang, 15857121122, wangxian@srrsh.com

    Recruiting

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

    Hangzhou

    Peifen Fu, 13958161556, fupeifen@hotmail.com

    Recruiting

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou

    Xiaohong Xie, 13957101427, xxh666857@163.com

    Recruiting

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

    Hebei

    Yunjiang Liu, 13703297890, lyj818326@163.com

    Recruiting

  • Xiangyang Central Hospital

    Hubei

    Yuehua Wang, 13995777482, 510839835@qq.com

    Recruiting

  • Xiangya Hospital Central South University

    Hunan

    Juan Huang, 13469081784, 375272151@qq.com

    Recruiting

  • Jieyang People's Hospital

    Jieyang

    Zhenhai Cai, 13502606100, 462975632@qq.com

    Recruiting

  • Shandong Province Tumor Hospital

    Jinan

    Yongqing Li, 15553115677, Liyq720917@126.com

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Wenlin Chen, 138 88087395, chenwenlin1@hotmail.com

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou

    Jie Hao, 13099203178, 523975396@qq.com

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou

    Xiaoling Ling, 18693165668, 86860306@qq.com

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Jingfen Wang, 15963976026, 2298641960@qq.com

    Recruiting

  • Luoyang Central Hospital

    Luoyang

    Mingli Ni, 15803795310, 928718761@qq.com

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Xinshuai Wang, 13837986128, xshuaiw@126.com

    Recruiting

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

    Luzhou

    Lijia He, 13619042857, 908380148@qq.com

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Zhengkui Sun, 13907000210, sunzhengkui616@163.com

    Recruiting

  • Nanchang People's Hospital

    Nanchang

    Chunwei Xie, 13006218563, 1875536028@qq.com

    Recruiting

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

    Nanjing

    Yongmei Yin, 86 13951842727, YongmeiYin_JSSRM@163.com

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing

    Li Xie, 13605169652, sherry01130@163.com

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning

    Yan Liu, 15877129696, liuyansunny@163.com

    Recruiting

  • Nanyang Central Hospital

    Nanyang

    Hao Zhang, 13703772883, nyzxyyzh@163.com

    Recruiting

  • The Second People's Hospital of Neijiang

    Neijiang

    Xujuan Wang, 13696038558, 61132803@qq.com

    Recruiting

  • Ningbo Medical Center Li Huili Hospital

    Ningbo

    WeiZhu Wu, 13957402451, 1144184462@qq.com

    Recruiting

  • The First People'S Hospital of Ping Ding Shan

    Pingdingshan

    Xiaohui Jing, jingxh120@163.com

    Recruiting

  • Qingdao Central Hospital, University of Health and Rehabilitation Sciences

    Qingdao

    Qiang Mu, 18561858307, mudoctor@163.com

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Haobo Wang, 18661805787, hbwangqy@126.com

    Recruiting

  • Quanzhou First Hospital

    Quanzhou

    Xiaofeng Li, 18965658239, 18965658239@189.cn

    Recruiting

  • Fudan University Cancer Center

    Shang’ai

    Zhimin Shao, 18017312288, szmgcp2016@163.com

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai

    Xiaohua Liang, 18121186232, xhliang66@sina.com

    Recruiting

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

    Shanghai

    GU Jianchun, 13764074162, gujianchun@126.com

    Recruiting

  • First Affiliated Hospital of Xi'an Jiaotong University

    Shanxi

    Jin Yang, 18991232383, 1473106133@qq.com

    Recruiting

  • The Central Hospital of Shaoyang

    Shaoyang

    Bin Dai, 15243901393, 490042498@qq.com

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Tao Sun, 18900917877, lnzlrxnsy@163.com

    Recruiting

  • Yuebei People's Hospital

    Shouguang

    Ruiwen Lei, 13826351682, leiruiwen2003@126.com

    Recruiting

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

    Sichuan

    Hao Wang, 13518204307, unique909@126.com

    Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin

    Chunfang Hao, 13602031629, haochf@163.com

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Yehui Shi, 18622221183, shiyehui@tjmuch.com

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi

    Bing Zhao, 13899908184, 819502412@qq.com

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Ouchen Wang, 13957706099, woc099@163.com

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Xinhong Wu, 86 18602726300, xinhongwuhbch@163.com

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technolog

    Wuhan

    Jing Yao, 13971139665, Jeaneyph@163.com

    Recruiting

  • The Second People's Hospital of WuHu

    Wuhu

    Hu Qin, 18055316155, huqin2007001@163.com

    Recruiting

  • The First Affiliated Hospital of Air Force Medical University

    Xi Ail

    Jing Fan, 13572961081, jingfan@vip.163.com

    Recruiting

  • The first affiliated hospital of Xiamen University

    Xiamen

    Zhong Ouyang, 18205962909, oyzlyl@163.com

    Recruiting

  • Zhongshang Hospital Xiamen University

    Xiamen

    Minjun Meng, 31455216@qq.com

    Recruiting

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xinzheng

    Shuqun Zhang, 13891841249, Zhangshuqun1971@aliyun.com

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Hongbing Wang, 15996969368, hbw0316@163.com

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Li Sun, 18052230275, xzsonya@sohu.com

    Recruiting

  • Yuncheng Central Hospital

    Yuncheng

    Xiaoke Hou, 17703591026, hxk13720980018@163.com

    Recruiting

  • Zhejiang cancer hospital

    Zhejiang

    Junqing Chen, 18658840965, 10918129@zju.edu.cn

    Recruiting

  • Zhejiang Provincial People's Hospital

    Zhejiang

    Xuli Meng, 13757128803, mxlmail@126.com

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Zhenzhen Liu, 13603862755, liuzhenzhen73@126.com

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Jingruo Li, 13939021305, jingruoli@163.com

    Recruiting

  • Zhongshan City People's Hospital

    Zhongshan

    Shihui Ma, 13620394254, shihui612@163.com

    Recruiting

  • Zhumadian Central Hospital

    Zhumadian

    Sen Xiang, 13839928053, xiangsen7@163.com

    Recruiting

Other trials in China

United States36 sites, 30 recruiting

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

    Ethan Binder, ebinder@phs.org

    Not yet recruiting

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

    Jane Meisel, jane.l.meisel@emory.edu

    Recruiting

  • Johns Hopkins Kimmel Cancer Center

    Baltimore, Maryland, 21231

    Jessica Tao, jtao10@jhmi.edu

    Recruiting

  • New Jersey Cancer Care, PA

    Belleville, New Jersey, 07109

    Withdrawn

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Seth Wander, SWANDER@mgh.harvard.edu

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Erica Mayer, erica_mayer@dfci.harvard.edu

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    S Berwick, sberwick@bidmc.harvard.edu

    Recruiting

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

    Takae Mizukami, Takae.Mizukami@UHhospitals.org

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44119

    Withdrawn

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

    Columbus, Ohio, 42112

    Daniel Stover, Daniel.Stover@osumc.edu

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Rani Bansal, 919-660-1278, rani.bansal@duke.edu

    Recruiting

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

    Completed

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Amy Vander Woude, avanderwoude@chcwm.com

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Ahmed Elkhanany, Ahmed.Elkhanany@bcm.edu

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Senthil Damodaran, SDamodaran@mdanderson.org

    Recruiting

  • Harris Health System - Smith Clinic

    Houston, Texas, 77054

    Ahmed Elkhanany, Ahmed.Elkhanany@bcm.edu

    Ahmed Elkhanany

    Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

    Clinical Trials Office - All Mayo Clinic Locations, 855-776-0015

    Recruiting

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

    Timothy Pluard, 816-932-3300, tpluard@saint-lukes.org

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    Laila Agrawal, laila.agrawal@nortonhealthcare.org

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33143

    Ana Sandoval Leon, AnaSand@baptisthealth.net

    Recruiting

  • Allina Health System DBA Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

    Completed

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Coral Omene, co273@cinj.rutgers.edu

    Recruiting

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

    Amy Tiersten, (212) 241-3300, amy.tiersten@mssm.edu

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Amy Tiersten, amy.tiersten@mssm.edu

    Recruiting

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

    New York, New York, 10065

    Sherry Shen, shens1@mskcc.org

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Completed

  • Miami Cancer Institute Plantation

    Plantation, Florida, 33324

    Ana Sandoval Leon, AnaSand@baptisthealth.net

    Recruiting

  • Renown Regional Medical Centre

    Reno, Nevada, 89502

    Lee Schwartzberg, Lee.Schwartzberg@renown.org

    Recruiting

  • Cancer Care Specialists

    Reno, Nevada, 89511-2250

    Sowjanya Reganti, sreganti@ccsreno.com

    Recruiting

  • Presbyterian Rust Cancer Center

    Rio Rancho, New Mexico, 87124

    Ethan Binder, ebinder@phs.org

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Office - All Mayo Clinic Locations, 855-776-0015

    Recruiting

  • Providence Medical Foundation - Santa Rosa, CA

    Santa Rosa, California, 95403

    Jarrod Holmes, jarrod.holmes@stjoe.org

    Recruiting

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona, 85259

    Clinical Trials Office - All Mayo Clinic Locations, 855-776-0015

    Recruiting

  • Swedish Cancer Institute (SCI)

    Seattle, Washington, 98104

    Withdrawn

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Nusayba Bagegni, nbagegni@wustl.edu

    Recruiting

  • University of Arizona - Cancer Center

    Tucson, Arizona, 85719

    Umbreen Rozell, uarshad@arizona.edu

    Recruiting

Other trials in United States

Italy14 sites, 12 recruiting

  • Azienda Ospedaliero-Universitaria delle Marche

    Ancona

    Rossana Berardi, rossana.berardi@ospedaliriuniti.marche.it

    Recruiting

  • Centro Riferimento Oncologico - Aviano

    Aviano

    Lorenzo Gerratana, (+39) 0434 659254, lgerratana@gmail.com; lorenzo.gerratana@cro.it

    Recruiting

  • La Fondazione e l'Istituto di Candiolo

    Candiolo, 10060

    Vanesa Gregorc, vanesa.gregorc@ircc.it

    Recruiting

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

    Meldola

    Michela Palleschi, +39 0543 739100, michela.palleschi@irst.emr.it

    Recruiting

  • Istituto Europeo di Oncologia

    Milan

    Marco Angelo Colleoni, 02-57489.970, marco.colleoni@ieo.it; emilia.montagna@ieo.it

    Recruiting

  • Humanitas Istituto Clinico Catanese

    Misterbianco

    Maria Vita Sanò, 09573390197, maria.vita_sano@ccocatania.it

    Recruiting

  • Azienda Ospedaliero-Universitaria di Modena

    Modena

    Luca Moscetti, +390594223244, moscetti.luca@aou.mo.it

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples

    Michelino De Laurentiis, +3908117770442, delauren@breastunit.org; m.delaurentiis@istitutotumori.na.it

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore Della Carita

    Novara, 28100

    Withdrawn

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

    Padova, 35128

    Valentina Guarneri, valentina.guarneri@unipd.it

    Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma

    Benedetta Pellegrino, benedetta.pellegrino@unipr.it

    bpellegrino@ao.pr.it

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Gianpiero Rizzo, g.rizzo@smatteo.pv.it

    Gianpiero Rizzo

    Recruiting

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

    Roma

    Emilio Bria, +390630155202, emiliobria@yahoo.it; emilio.bria@policlinicogemelli.it

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

    Verona

    Completed

Other trials in Italy

France13 sites, 13 recruiting

  • Institut Sainte Catherine

    Avignon, 84000

    Julien Grenier, j.grenier@isc84.org

    Recruiting

  • Service d'Oncologie Medicale - CHRU Besancon

    Besançon

    Laura Mansi, lmansi@chu-besancon.fr

    Recruiting

  • Institut Bergonie

    Bordeaux

    Marc Debled, +33 (0)5 56 33 04 77, M.Debled@bordeaux.unicancer.fr

    Recruiting

  • Centre Francois Baclesse

    Caen

    George Emile, g.emile@baclesse.unicancer.fr

    Recruiting

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

    Le Mans, 72015

    Sophie Roche, essaisroche@ilcgroupe.fr

    Recruiting

  • Centre Oscar Lambret

    Lille

    Charlotte Bellier, +33 (0)3.20.29.59.59, investigation@o-lambret.fr;c-bellier@o-lambret.fr

    Recruiting

  • Centre Leon Berard

    Lyon

    Thomas Bachelot, +33 4 78 78 26 54, thomas.bachelot@lyon.unicancer.fr

    Recruiting

  • Institut Paoli-Calmettes

    Marseille

    Alexandre Tassin de Nonneville, +33491223789, tassindenonnevillea@ipc.unicancer.fr

    Recruiting

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

    Julien Peron, julien.peron@chu-lyon.fr

    Recruiting

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

    Poitiers

    Nicolas Isambert, nicolas.isambert@chu-poitiers.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Marianne Leheurteur, marianne.leheurteur@chb.unicancer.fr

    Recruiting

  • Institut Claudius Regaud

    Toulouse

    Florence Dalenc, (+33) 5 31 15 51 22, dalenc.florence@iuct-oncopole.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Alessandro Viansone, Alessandro.viansone@gustaveroussy.fr

    Recruiting

Other trials in France

Spain13 sites, 13 recruiting

  • Hospital Clinic Barcelona

    Barcelona

    Tomas Pascual, topascual@clinic.cat

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona

    Miriam Arumi de Dios, +34600240679, marumi@vhio.net

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba

    Juan de la Haba, juahaba@gmail.com

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Noelia Martinez Jañez, mjnoelia@hotmail.com

    Recruiting

  • Hospital Fundacion Jimenez Diaz

    Madrid, 28040

    Yann Izarzugaza, yizarzugaza@quironsalud.es

    Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid

    Jaime Espinos Jimenez, jespinos@unav.es

    Recruiting

  • Hospital Beata Maria Ana

    Madrid

    Javier Cortes Castan, +34 935 460 139, javierr.cortes@maj3.health

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid

    Sara Lopez- Tarruella Cobo, slopeztarruella@gmail.com

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Eva Ciruelos Gil, +34913908000, evaciruelos.h12o@gmail.com

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid

    Ana Isabel Ballesteros, +34915202200, oncologiamedica.princesa@outlook.com

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga

    Begoña Jimenez Rodríguez, bego.jimenez@ibima.eu

    begojrodriguez@gmail.com

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona

    Jaime Espinos Jimenez, jespinos@unav.es

    Recruiting

  • Instituto Valenciano de Oncologia

    Valencia

    Angel Guerrero Zotano, +34 96 111 4051, aguerrero@fivo.org

    Recruiting

Other trials in Spain

Israel10 sites, 10 recruiting

  • Haemek Medical Center

    Afula, 1834111

    Gil Bar-Sela, gil_ba@clalit.org.il

    Recruiting

  • Soroka Medical Center

    Beersheba, 8486614

    Wael Hozaeel, waelhz@clalit.org.il

    Recruiting

  • Rambam Health Care Campus

    Haifa

    Ayelet Shai, A_SHAI@rambam.health.gov.il

    Recruiting

  • Hadassah Ein-Karem Medical Center

    Jerusalem

    Ofra Maimon, +972505172570, ofra406@hadassah.org.il

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem

    Ora Solange Rosengarten, rosengarten@szmc.org.il

    Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164

    Iryna Kuchuk, iryna.kuchuk@clalit.org.il

    Recruiting

  • Rabin MC

    Petah Tikva

    Rinat Yerushalmi, rinaty@clalit.org.il

    Recruiting

  • Kaplan Medical Center

    Rehovot

    Adi Rasco, 972-524610814, adifar@clalit.org.il

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Amir Sonnenblick, amirson@tlvmc.gov.il

    Recruiting

  • Sheba Medical Center

    Tel HaShomer

    Einav Nili Gal-Yam, +972-3-5302243, Einav.NiliGal-Yam@sheba.health.gov.il

    Recruiting

Other trials in Israel

Turkey (Türkiye)10 sites, 10 recruiting

  • Ankara University Medical Faculty Medical Oncology Department

    Ankara

    Arzu Yasar, hayasar@ankara.edu.tr

    Recruiting

  • Ege University Medical Faculty Hospital

    Bornova, İzmir

    Burcu Cakar, burcu.cakar@gmail.com

    Not yet recruiting

  • Uludag University Faculty of Medicine Hospital

    Bursa

    Turkkan Evrensel, evrensel@uludag.edu.tr

    Recruiting

  • Liv Hospital Ankara

    Çankaya, Ankara

    Saadettin Kilickap, skilickap@yahoo.com

    Recruiting

  • Istanbul University CAPA Medical Faculty

    Çapa, Istanbul

    Meltem Ekenel, meltemekenel@yahoo.com

    Recruiting

  • Trakya University Medical Faculty Hospital

    Edirne

    Sernaz Topaloglu, sernaz.uzunoglu@gmail.com

    Recruiting

  • Medical Point Izmir Hospital

    Izmir

    Cagatay Arslan, arslancagatay@yahoo.com

    Recruiting

  • Kocaeli University Research and Application Hospital

    İzmit, Kocaeli

    Devrim Cabuk, devrim.cabuk@kocaeli.edu.tr

    devrimcabuk@yahoo.com

    Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadiköy, Istanbul

    Mahmut Gumus, mgumus@superonline.com

    Recruiting

  • Suat Seren Training and Research Hospital

    Konak, İzmir

    Sema Erturk, drsemaerturk@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom9 sites, 8 recruiting

  • Velindre Cancer Center

    Cardiff, CF14 2TL

    Simon Waters, simon.waters@wales.nhs.uk

    Recruiting

  • Princess Alexandra Hospital - Harlow

    Harlow, CM20 1QX

    Apostolos Konstantis, a.konstantis@nhs.net

    Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds

    Chris Twelves, C.J.Twelves@leeds.ac.uk

    Recruiting

  • Royal Free London NHS Foundation Trust

    London, NW3 2

    Judy King, judy.king@nhs.net

    Recruiting

  • Charing Cross Hospital

    London

    Farah Rehman, f.rehman@nhs.net

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Anne Armstrong, anne.armstrong3@nhs.net

    Recruiting

  • Milton Keynes Hospital

    Milton Keynes, MK6 5LD

    Azhar Rizvi, azhar.rizvi@mkuh.nhs.net

    Recruiting

  • Nottingham City Hospital

    Nottingham

    Sarah Khan, sarah.khan69@nhs.net

    Recruiting

  • University Hospital of North Tees

    Stockton-on-Tees, TS198PE

    Withdrawn

Other trials in United Kingdom

Poland8 sites, 5 recruiting

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

    Biała Podlaska

    Withdrawn

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

    Gliwice

    Withdrawn

  • SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej

    Krakow

    Piotr Wysocki, 48 12 424-89-12, piotr.wysocki@uj.edu.pl; klinikaonkologii@su.krakow.pl

    Recruiting

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

    Krakow

    Anna Kowalczyk-Tekiela, +48 502 315 790, atekiela@interia.pl

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii

    Lodz

    Completed

  • Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii

    Poznan

    Rodryg Ramlau, +48513155613, rramlau@gmail.com

    Recruiting

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

    Poznan

    Anna Szafryna-Kliwicka, +48618850620, anna.szafryna-kliwicka@wco.pl

    Recruiting

  • Mazowiecki Szpital Onkologiczny

    Wieliszew

    Sylwina Socha, +48 22 766 15 00 ext. 134, s.socha@szpitalonkologiczny.pl

    Recruiting

Other trials in Poland

Romania7 sites, 5 recruiting

  • Centrul Medical Focus

    Bucharest

    Withdrawn

  • Memorial Healthcare International SRL

    Bucharest

    Ingrid Iordan, 0721298677, mireliordan@yahoo.com

    Recruiting

  • Radiotherapy Center Cluj

    Cluj-Napoca

    Andrei Ungureanu, +40742206212, andreiungureanu.oncolog@yahoo.com

    Recruiting

  • Onco Clinic Consult SA

    Craiova

    Completed

  • Oncology Center Sfantul Nectarie

    Craiova

    Michael Schenker, +40351401336, mike_schenker@yahoo.com

    Recruiting

  • Gral Medical SRL

    Piteşti

    Adela-Luiza Chirila, +40766442720, dr.adela_chirila@yahoo.com

    Recruiting

  • OncoMed Oncology Center

    Timișoara

    Daniela Sirbu, +40 0744571617, desirbu@yahoo.com

    Recruiting

Other trials in Romania

Taiwan7 sites, 7 recruiting

  • Changhua Christian Hospital (CCH)

    Changhua

    Shou-Tung Chen, 1886@cch.org.tw

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung City

    Ming-Feng Hou, mifeho@kmu.edu.tw

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Wei-Pang Chung, +886975014242, edgarbun@gmail.com

    Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei

    Chi-Feng Chung, cheh@kfsyscc.org

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Chiun-Sheng Huang, huangcs@ntu.edu.tw

    Recruiting

  • Tri-Service General Hospital

    Taipei

    Ming-Shen Dai, +886-2-87927208, dms1201@gmail.com

    Recruiting

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City

    Chi-Chang Yu, kenneth0609@cgmh.org.tw

    Recruiting

Other trials in Taiwan

Canada5 sites, 4 recruiting

  • Hospital Maisonneuve-Rosemont

    Montreal, Quebec

    Jonathan Noujaim, jonathan.noujaim.med@ssss.gouv.qc.ca

    Recruiting

  • Lady Davis Institute for Medical Research Jewish General Hospital

    Montreal, Quebec

    Parvaneh Fallah, parvaneh.fallah@mail.mcgill.ca

    Recruiting

  • The Ottawa General Hospital

    Ottawa, Ontario

    Terry Ng, teng@toh.ca

    Recruiting

  • CIUSSS du Saguenay-Lac-Saint-Jean

    Saguenay, Quebec

    Withdrawn

  • Sunnybrook Health Sciences Centre -Bayview Campus

    Toronto, Ontario

    Rossanna Pezo, 416-480-4757, rossanna.pezo@sunnybrook.ca

    Recruiting

Other trials in Canada

South Korea5 sites, 3 recruiting

  • National Cancer Center

    Gyeonggi-do

    Keun Seok Lee, kslee@ncc.re.kr

    Recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Hyun Jeong Shim, 82-61-379-7634, hjnhj@chonnam.ac.kr

    Recruiting

  • Asan Medical Center

    Seoul

    Withdrawn

  • Korea University Anam Hospital

    Seoul

    Kyong Hwa Park, 82-2-920-6841, khpark@korea.ac.kr

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Withdrawn

Other trials in South Korea

Belgium4 sites, 3 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels

    Francois Duhoux, +32 2 764 51 06, francois.duhoux@saintluc.uclouvain.be

    Recruiting

  • Antwerp University Hospital (UZA)

    Edegem

    Withdrawn

  • Universitaire Ziekenhuizen Leuven

    Leuven

    Patrick Neven, patrick.neven@uzleuven.be

    Recruiting

  • CHU UCL Namur - Site De Sainte-Elisabeth

    Namur

    Donatienne Taylor, 003281720524, donatienne.taylor@chuuclnamur.uclouvain.be; donatienne.taylor@uclouvain.be

    Recruiting

Other trials in Belgium

Australia3 sites, 3 recruiting

  • Blacktown Hospital

    Blacktown

    Jennifer Man, jennifer.man@health.nsw.gov.au

    Recruiting

  • Concord Repatriation General Hospital

    Concord

    Belinda Kiely, +61 02 9767 6354, belinda.kiely@health.nsw.gov.au

    Recruiting

  • Mater Misericordiae Ltd, South Brisbane

    South Brisbane

    Kathryn Middleton, +61 07 31632531, kathryn.middleton@mater.org.au

    Recruiting

Other trials in Australia

Germany2 sites, 2 recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden

    Pauline Wimberger, +49 (0)351 458-6728, pauline.wimberger@uniklinikum-dresden.de

    Recruiting

  • Klinikum rechts der Isar der Technischen Universitaet Muenchen

    München

    Evelyn Klein, 089 4140 2433, evelyn.klein@tum.de

    Recruiting

Other trials in Germany

Singapore1 site, 1 recruiting

  • Curie Oncology

    Singapore, 329563

    Su-Mien Lynette Ngo, +6562595538, lynettengo@curieoncology.com.sg

    Recruiting

Other trials in Singapore

About this study

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

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.
Being tested
Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Lasofoxifene in combination with abemaciclibDrug

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

  • Fulvestrant in combination with abemaciclibDrug

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

Study groups in NCT05696626
Study groupRoleWhat they receive
TreatmentExperimentalPre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Receives: Drug: Lasofoxifene in combination with abemaciclib
Reference TherapyActive comparatorPre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Receives: Drug: Fulvestrant in combination with abemaciclib

What is being measured

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

  1. Progression free survival (PFS)

    PFS is defined as the time from the date of randomization [Visit 0 (Day 1)] to the earliest date of first documented progression per RECIST 1.1 as determined by BICR or death due to any cause.

    Measured: Within approximately 3 years

Secondary outcomes (8)

  1. Objective response rate (ORR)

    ORR is defined as the percentage of subjects with measurable disease at baseline whose best overall response is either a confirmed CR or a confirmed PR according to RECIST 1.1.

    Measured: Within approximately 3 years

  2. Overall survival (OS)

    Overall survival is defined as time from the date of Visit 0 (Day 1) to death due to any cause.

    Measured: Within approximately 3 years

  3. Clinical benefit rate (CBR)

    CBR is defined as the percentage of subjects with best overall response of confirmed CR, confirmed PR, or stable disease (SD) with a duration of 24 weeks or longer according to RECIST 1.1. As used in this calculation, stable disease is defined as stable disease in those subjects with measurable disease plus nonPR/non progressive disease (PD) in subjects with non-measurable disease.

    Measured: Within approximately 3 years

  4. Duration of response (DoR) in subjects with an objective response

    DoR is from the date of first documented confirmed response (CR or PR) to the date of first documented progression of disease or death due to any cause, whichever is earlier.

    Measured: Within approximately 3 years

  5. Time to response (TTR) in subjects with an objective response

    TTR is from the date of randomization to the date of first documented confirmed response (CR or PR).

    Measured: Within approximately 3 years

  6. Time to cytotoxic chemotherapy

    From the date of randomization to the date of first documented use of cytotoxic chemotherapy.

    Measured: Within approximately 3 years

  7. Quality of Life (QoL) evaluated using the Functional Assessment of Cancer Therapy-Breast Cancer-Endocrine Subscale (FACT B-ES)

    Scale ranges from 'Not at all' to 'Very much'

    Measured: Within approximately 3 years

  8. Incidence of Adverse Events (AEs) and Serious AEs

    The type, severity (graded by Common Terminology Criteria for Adverse Events [CTCAE version 5.0]), course, duration, seriousness, and relationship to study treatment will be assessed at each visit

    Measured: Within approximately 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 posted25 Jan 2023
  2. Study start31 Oct 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open label, randomized, parallel-group, multicenter study
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696626
Sponsor's protocol ID
SMX 22-002
Acronym
ELAINEIII
Status last verified
Oct 2026
First submitted
13 Jan 2023
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goetz MP, Wander SA, Bachelot T, de Nonneville A, Gal-Yam EN, Sammons SL, Shen S, Twelves C, Boruta G, Portman DJ, Damodaran S. ELAINE 3: phase 3 study of lasofoxifene plus abemaciclib to treat ER+/HER2-, ESR1-mutated, metastatic breast cancer. Future Oncol. 2025 May;21(11):1317-1324. doi: 10.1080/14796694.2025.2481825. Epub 2025 Apr 13.

    PubMed 40222048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib in people with Metastatic Breast Cancer, run by LeonaBio at 224 sites in 17 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 17 inclusion and 25 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 29 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 224 sites in China, United States, Italy, France, Spain and 12 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Simon Daggett - Senior Vice President, Clinical Operations ((909) 374-3793 ext. (425) 620-8772, clinicaltrials@leonabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: Within approximately 3 years). 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 NCT05696626, which also lists 1 linked publication.

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 29 Oct 2026.

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