Breast NeoplasmsPhase 3EMBER-3NCT04975308
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
A Phase 3 study testing Imlunestrant, Exemestane and Fulvestrant in people with Breast Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 243 sites in 22 countries.
Trial summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- Imlunestrant, Exemestane and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 243 sitesin 22 countries
- Study dates
- 4 Oct 2021to Aug 2027
- Phase
- Phase 3
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
- Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
- Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
- -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
- Must be deemed appropriate for treatment with endocrine therapy
- If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
- Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Show all 9Show fewer
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
- Have adequate renal, hematologic, and hepatic organ function
- Must be able to swallow capsules/tablets
Who cannot join
- Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
- Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
- Have symptomatic or untreated brain metastasis.
- Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
- Known allergic reaction against any of the components of the study treatment
Trial locations and contacts
243 sites in 22 countries.
243 sites in 22 countries
United States48 sites
USO - Texas Oncology - Allen
Allen, Texas, 75013
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
Aultman Hospital
Canton, Ohio, 44710
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
Clermont Oncology Center
Clermont, Florida, 34711
Care Access - Clifton
Clifton, New Jersey, 07013
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois, 60201
University of Florida College of Medicine
Gainesville, Florida, 32610
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Marin Cancer Care
Greenbrae, California, 94904
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Willamette Valley Cancer Institute & Research Ctr.
Houston, Texas, 77070
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Texas Oncology - Carrollton
Lewisville, Texas, 75056
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538
Memorial Sloan Kettering - Bergen
Montvale, New Jersey, 07645
IU Health Ball Memorial Hospital, Inc.
Muncie, Indiana, 47303
Florida Cancer Specialists
Nashville, Tennessee, 37203
The Mark H Zangmeister Cancer Center
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Sharp Memorial Hospital
San Diego, California, 92123
Florida Cancer Specialists
Sarasota, Florida, 34232
Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, 57105
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Texas Oncology - Denison
The Woodlands, Texas, 75020
Texas Oncology - Paris
The Woodlands, Texas, 75460
Blue Ridge Cancer Care
The Woodlands, Texas, 77380
Broome Oncology
The Woodlands, Texas, 77380
Minnesota Oncology/Hematology PA
The Woodlands, Texas, 77380
Texas Oncology - Carrollton
The Woodlands, Texas, 77380
Texas Oncology - McKinney
The Woodlands, Texas, 77380
Texas Oncology - Medical City Dallas
The Woodlands, Texas, 77380
Texas Oncology - Methodist Charlton Cancer Center
The Woodlands, Texas, 77380
Texas Oncology - San Antonio Medical Center
The Woodlands, Texas, 77380
Texas Oncology - The Woodlands
The Woodlands, Texas, 77380
Texas Oncology - Willowbrook
The Woodlands, Texas, 77380
Texas Oncology Fort Worth
The Woodlands, Texas, 77380
Texas Oncology-Baylor Charles A. Sammons Cancer Center
The Woodlands, Texas, 77380
USO-Rocky Mountain Cancer Center
The Woodlands, Texas, 77380
Texas Oncology - Austin Central
The Woodlands, Texas, 78731
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
China31 sites
Beijing Hospital
Beijing, Beijing Municipality, 100005
Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
The Second Hospital of Jilin University
Changchun, Jilin
The First People's Hospital of Changde City
Changde, Hunan, 415003
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Hunan Cancer Hospital
Changsha, Hunan, 421000
Sichuan Cancer hospital
Chengdu, Sichuan, 610042
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, 511400
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Jiangmen Center Hospital
Jiangmen, Guangdong
Jinan Central Hospital
Jinan, Shandong, 250013
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Nanyang Second General Hospital
Nanyang, Henan, 473000
The Second People's Hospital of Neijiang
Neijiang, Sichuan, 641000
Hwa Mei Hospital University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010
Ningbo Medical Center
Ningbo, Zhejiang, 315048
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Zhongshan Peoples Hospital
Zhongshan, Guangdong, 528403
The Fifth Affiliated Hospital of Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Japan22 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
Chiba cancer center
Chiba, Chiba, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Hiroshima City Hospital
Hiroshima, 730-8518
Sagara Hospital
Kagoshima, 892-0833
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Shinko Hospital
Kobe, Hyōgo, 651-0072
Kumamoto Shinto General Hospital
Kumamoto, 862-8655
Kurume General Hospital
Kurume, Fukuoka, 830-0013
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Osaka International Cancer Institute
Osaka, 541-8567
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Showa University Hospital
Shinagawa, Tokyo, 142-8555
Shizuoka General Hospital
Shizuoka, 420-8527
Juntendo University Hospital
Tokyo, 113-8431
Nagano Municipal Hospital
Tomitake, Nagano, 381-8551
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, 300-0028
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Turkey (Türkiye)16 sites
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250
University of Health Sciences,Gulhane School of Medicine
Ankara, 06010
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, 06200
Hacettepe Universitesi
Ankara, 06230
Memorial Ankara Hastanesi
Ankara, 06520
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
Akdeniz Universitesi Hastanesi
Antalya, 07059
Dicle Üniversitesi
Diyarbakır, 21200
Trakya University
Edirne, 22030
Acıbadem Maslak Hastanesi
Istanbul, 34457
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Ege Universitesi Hastanesi
Izmir, 35100
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya, 44280
Mersin University
Mersin, 33343
Medipol University Medical Faculty
Stanbul, Istanbul, 34214
Acibadem Altunizade Hospital
Üsküdar / Stanbul, Istanbul
Spain13 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Hospital Universitari Dexeusa
Barcelona, Catalunya [Cataluña], 08028
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Hospital San Pedro de Alcántara
Cáceres, Extremadura, 10003
Hospital Universitario San Cecilio
Granada, 18016
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], 25198
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Hospital Quirónsalud Valencia
Valencia, València, 46010
South Korea12 sites
Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, 49201
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, Chungcheongnam-do [Chungnam], 31151
Yeungnam Univeristy Medical Center
Daegu, Kyǒngsangbuk-do, 42415
Kyungpook National University Chilgok Hospital
Daegu, Taegu-Kwangyǒkshi, 41404
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03181
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Gangnam Severance Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06273
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
France9 sites
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, 64109
CHU Besançon
Besançon, Doubs, 25000
Polyclinique De Blois
La Chaussée-Saint-Victor, Centre-Val de Loire, 41260
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, 72000
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon, 34070
Institut Curie
Paris, 75248
Hôpital René Huguenin
Saint-Cloud, Hauts-de-Seine, 92210
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace, 67033
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Germany9 sites
Onkologiezentrum Donauwörth
Donauwörth, Bavaria, 86609
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, 60431
Gynäkologisch-Onkologische Praxis am Pelikanplatz
Hanover, Lower Saxony, 30177
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, North Rhine-Westphalia, 41061
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, 80336
India9 sites
Medstar Speciality Hospital
Bangalore, Karnataka, 560092
Yashoda Hospitals
Hyderabad, Telangana, 500082
HCG Cancer Centre
Mumbai, Maharashtra, 400092
Government Medical College And Hospital - Nagpur
Nagpur, Maharashtra, 440003
Rashtrasant Tukdoji Regional Cancer Hospital
Nagpur, Maharashtra, 440027
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011
Mexico9 sites
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Álvaro Obregón, Mexico City, 01330
Unidad de Investigación en Salud
Chihuahua City, 31203
Grupo Medico Camino Sc
Mexico City, Mexico City, 03310
Private Practice - Dr. Joaquin Reinoso
Monterrey, Nuevo León, 64320
Filios Alta Medicina
Monterrey, Nuevo León, 64460
Oaxaca Site Management Organization
Oaxaca City, 68000
Unidad Médica Onco-hematológica
Puebla City, 72424
Centro Medico Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
Centro de Investigación Clínica de Alta Especialidad
Torreón, Coahuila, 27010
Argentina8 sites
CIPREC
Buenos Aires, Buenos Aires F.D., C1061AAS
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, 1122
Fundación Cenit Para La Investigación En Neurociencias
CABA, Buenos Aires F.D., 1125
Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FZO
Instituto San Marcos
San Juan, 5400
Sanatorio Norte
Santiago del Estero, 4200
Clinica Viedma
Viedma, Río Negro Province, 8500
Belgium8 sites
Imelda General Hospital
Bonheiden, Antwerpen, 2820
Institut Jules Bordet
Brussels, Bruxelles-Capitale, Région de, 1000
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090
UZ Gent
Ghent, Oost-Vlaanderen, 9000
AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen, 8500
UZ Leuven
Leuven, Vlaams-Brabant, 3000
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, B-9100
Greece8 sites
Agios Savvas Regional Cancer Hospital
Athens, Attikí, 115 22
Alexandra Hospital
Athens, Attikí, 115 28
University General Hospital of Heraklion
Heraklion, Irakleío, 711 10
University General Hospital of Larissa
Larissa, Thessalía, 41110
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, Attikí, 14564
Euromedica General Clinic of Thessaloniki
Thessaloniki, Thessaloníki, 546 45
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01
Italy7 sites
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Ospedale San Martino
Genoa, Liguria, 16132
University of Naples Federico II
Naples, Campania, 80100
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131
Istituto Oncologico Veneto IRCCS
Padova, 35128
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
Australia5 sites
Box Hill Hospital
Box Hill, Victoria, 3128
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
Maroondah Hospital
Melbourne, Victoria, 3135
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Brazil5 sites
Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
São Paulo, 01317-001
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, 04014-002
Czechia5 sites
Nemocnice Horovice
Hořovice, Beroun, 268 31
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, 10034
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
Nemocnice Na Bulovce
Prague, Praha 8, 180 81
Oblastni nemocnice Pribram
Příbram, Příbram, 261 01
Taiwan5 sites
Taichung Veterans General Hospital
Taichung, 407
Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Ukraine5 sites
CNPE "Regional Center of Oncology"
Kharkiv, Kharkiv Oblast, 61070
Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Oblast, 50048
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
Lutsk, Volyn Oblast, 43018
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, 65025
Uzhgorod Central City Clinical Hospital
Uzhhorod, Zakarpattia Oblast, 88000
Austria3 sites
Medizinische Universität Graz
Graz, Styria, 8036
Uniklinikum Salzburg
Salzburg, 5020
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, State of Vienna, 1090
Netherlands3 sites
Medische Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Haga Ziekenhuis locatie Leyweg
The Hague, South Holland, 2545 AA
Russia3 sites
Kaluga Regional Clinical Oncology Center
Kaluga, Kalužskaja Oblast', 248007
N.N.Petrov Research Institute of Oncology
Saint Petersburg, 197758
Volgograd Regional Clinical Cancer Clinic No.1
Volgograd, Volgograd Oblast, 400138
About this study
Official title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- Imlunestrant, Exemestane, Fulvestrant, Abemaciclib
- Keywords
- SERD
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlunestrantDrug
Also called LY3484356
Administered orally.
ExemestaneDrug
Administered orally.
FulvestrantDrug
Administered IM.
AbemaciclibDrug
Also called LY2835219
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Imlunestrant | Experimental | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. Receives: Drug: Imlunestrant |
| Arm B: Investigator's Choice of Endocrine Therapy | Experimental | Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. Receives: Drug: Exemestane; Drug: Fulvestrant |
| Arm C: Imlunestrant + Abemaciclib | Experimental | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. Receives: Drug: Imlunestrant; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Investigator-assessed PFS (Between Arm C and Arm A)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Secondary outcomes (18)
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 25 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Measured: Randomization until measured progressive disease (up to 28 months)
Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Randomization until measured progressive disease (up to 28 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Measured: Randomization until measured progressive disease (up to 26 months)
Investigator-assessed Duration of Response (DoR) (Between Arm C and Arm A)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm C and Arm A)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Randomization until measured progressive disease (up to 26 months)
Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm A and Arm B)
Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
Measured: Randomization through follow-up (up to 24 months)
Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A)
Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
Measured: Randomization through follow-up (up to 20 months)
Pharmacokinetics (PK): Plasma Concentration of Imlunestrant
- Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing.
- For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
Measured: Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib
- Plasma concentration of total abemaciclib is the concentration of the parent abemaciclib and its metabolites in the plasma.
- Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing.
- For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
Measured: Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
Overall Survival (OS) in the ITT Population
OS in the ITT population
Measured: Randomization until death from any cause (estimated as up to 5 years)
OS in the ESR1-mutation Detected Population
OS in the ESR1-mutation detected population
Measured: Randomization until death from any cause (estimated as up to 5 years)
Blinded Independent Review Committee (BIRC) Assessed PFS in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Measured: Randomization until measured progressive disease (up to 28 months)
Investigator-assessed Duration of Response (DoR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Measured: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Randomization until measured progressive disease (up to 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start4 Oct 2021
- Primary completion24 Jun 2024
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975308
- Sponsor's protocol ID
- 18175
- Other IDs
- J2J-OX-JZLC, 2021-000079-35, 2023-506786-63-00, 2023
- Acronym
- EMBER-3
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2021
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Jhaveri KL, Neven P, Casalnuovo ML, Kim SB, Tokunaga E, Aftimos P, Saura C, O'Shaughnessy J, Harbeck N, Carey LA, Curigliano G, Llombart-Cussac A, Lim E, Garcia Tinoco ML, Sohn J, Mattar A, Zhang Q, Huang CS, Hung CC, Martinez Rodriguez JL, Ruiz Borrego M, Nakamura R, Pradhan KR, Cramer von Laue C, Barrett E, Cao S, Wang XA, Smyth LM, Bidard FC; EMBER-3 Study Group. Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. N Engl J Med. 2025 Mar 27;392(12):1189-1202. doi: 10.1056/NEJMoa2410858. Epub 2024 Dec 11.
PubMed 39660834