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
NCT ID: NCT05696626
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2023-10-31
2028-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Pre- 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.
Lasofoxifene in combination with abemaciclib
5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
Reference Therapy
Pre- 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.
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
Interventions
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Lasofoxifene in combination with abemaciclib
5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
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
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Histological or cytological confirmation of ER+/HER2 - disease
4. No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.
5. 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.
6. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.
7. 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.
8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
9. Adequate organ function
10. Able to swallow tablets
11. Brain metastases are allowed only if the following 4 parameters hold:
1. Asymptomatic,
2. Definitively treated (e.g., radiotherapy, surgery),
3. Not requiring steroids up to 4 weeks before study treatment initiation, AND
4. Central nervous system disease stable for \>3 months prior to registration as documented by magnetic resonance imagining (MRI).
12. Able to understand and voluntarily sign a written informed consent before any screening procedures.
13. 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
Exclusion Criteria
2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients
6. 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).
7. 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.)
8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of \>480 msec.
9. 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).
10. 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).
11. On concomitant strong CYP3A4 inhibitors.
12. On strong and moderate CYP3A4 inducers.
13. Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.
14. Active systemic bacterial or fungal infection (requiring intravenous \[IV\] antibiotics or antifungals at the time of initiating study treatment).
15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
16. 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.
17. Positive serum pregnancy test (only if premenopausal).
18. Sexually active premenopausal women and men unwilling to use double-barrier contraception.
19. Women who are breast feeding
20. History of non-compliance to medical regimens.
21. Unwilling or unable to comply with the protocol.
22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
18 Years
ALL
No
Sponsors
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Sermonix Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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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 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
Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita
Novara, , Italy
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
Padua, , 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
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
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Office - All Mayo Clinic Locations
Role: primary
Clinical Trials Office - All Mayo Clinic Locations
Role: primary
Clinical Trials Office - All Mayo Clinic Locations
Role: primary
Xiaoling Liu
Role: primary
Alessandro Viansone
Role: primary
Role: backup
Role: backup
Role: backup
Simon Waters
Role: primary
References
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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.
Other Identifiers
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SMX 22-002
Identifier Type: -
Identifier Source: org_study_id
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