A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Breast Neoplasms Clinical Trial

— EMBER-3  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975308
• Other study ID #: 18175
• Secondary ID: J2J-OX-JZLC2021-
• Status: Recruiting
• Phase: Phase 3
• Start date: October 4, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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-). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: August 31, 2027
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Imlunestrant
Administered orally.
• Exemestane
Administered orally.
• Fulvestrant
Administered IM.
• Abemaciclib
Administered orally.

Locations

Country	Name	City	State
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Instituto Argentino de Diagnóstico y Tratamiento (IADT)	Buenos Aires
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Centro Medico Privado CEMAIC	Capital	Córdoba
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Instituto San Marcos	San Juan
Argentina	Sanatorio Norte	Santiago del Estero
Argentina	Clinica Viedma	Viedma	Río Negro
Australia	Cancer Research SA	Adelaide	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Maroondah Hospital	Melbourne	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Uniklinikum Salzburg	Salzburg
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	Imelda General Hospital	Bonheiden	Antwerpen
Belgium	UZ Brussel	Brussels	Bruxelles-Capitale, Région De
Belgium	Institut Jules Bordet	Bruxelles	Bruxelles-Capitale, Région De
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen
Brazil	Hospital de Cancer de Londrina	Londrina	Paraná
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA	São Paulo
Brazil	Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo
China	Beijing Hospital	Beijing	Beijing
China	Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	Afflilated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The First People's Hospital of Changde City	Changde	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Provincial People's Hospital	ChangSha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sichuan Cancer hospital	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Centre	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jiangmen Center Hospital	Jiangmen	Guangdong
China	Jinan Central Hospital	Jinan	Shandong
China	Jining Medical University - Affiliated Hospital	Jining	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanyang Second General Hospital	Nanyang	Henan
China	The Second People's Hospital of Neijiang	Neijiang	Sichuan
China	Hwa Mei Hospital University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Ningbo Medical Center	Ningbo	Zhejiang
China	Tianjin Medical University Cancer Institute and Hospital	Tianjing	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
Czechia	Nemocnice Horovice	Horovice	Beroun
Czechia	Fakultni nemocnice Bulovka	Prague	Praha 8
Czechia	Fakultni nemocnice Kralovske Vinohrady	PRague	Praha 10
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Czechia	Oblastni nemocnice Pribram	Pribram	Príbram
France	Centre Hospitalier de la Côte Basque	Bayonne	Pyrénées-Atlantiques
France	CHU Besançon	Besançon	Doubs
France	Polyclinique De Blois	La Chaussée-Saint-Victor	Centre
France	Clinique Victor Hugo Le Mans	Le Mans	Pays-de-la-Loire
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
France	Institut Curie	Paris
France	Institut Curie - site Saint-Cloud	Saint-Cloud	Hauts-de-Seine
France	Institut de cancérologie Strasbourg Europe (ICANS)	Strasbourg	Alsace
France	Institut de Cancérologie de Lorraine Alexis Vautrin	Vandoeuvre-lès-Nancy
Germany	Onkologiezentrum Donauwörth	Donauwörth	Bayern
Germany	Universitaetsklinikum Erlangen	Erlangen	Bayern
Germany	Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung	Essen	Nordrhein-Westfalen
Germany	Agaplesion Markus Krankenhaus	Frankfurt	Hessen
Germany	Gynäkologisch-Onkologische Praxis am Pelikanplatz	Hannover	Niedersachsen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg
Germany	Evangelisches Krankenhaus Bethesda Mönchengladbach	Mönchengladbach	Nordrhein-Westfalen
Germany	Klinikum der Ludwig-Maximilians-Universitaet Muenchen	München	Bayern
Greece	Agios Savvas Regional Cancer Hospital	Athens	Attikí
Greece	Alexandra Hospital	Athens	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University General Hospital of Larissa	Larissa	Thessalía
Greece	General Oncology Hospital of Kifissia "Agioi Anargiroi"	Nea Kifissia	Attikí
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki	Thessaloníki
Greece	European Interbalkan Medical Center	Thessaloniki	Thessaloníki
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki	Thessaloníki
India	Medstar Speciality Hospital	Bangalore	Karnataka
India	Yashoda Hospitals	Hyderabad	Telangana
India	HCG Cancer Centre	Mumbai	Maharashtra
India	Government Medical College And Hospital - Nagpur	Nagpur	Maharashtra
India	Rashtrasant Tukdoji Regional Cancer Hospital	Nagpur	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Lifepoint Multispeciality Hospital	Pune	Maharashtra
India	Regional Cancer Centre - Thiruvananthapuram	Thiruvananthapuram	Kerala
Italy	Cro-Irccs	Aviano	Friuli-Venezia Giulia
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Ospedale San Martino	Genova	Liguria
Italy	University of Naples Federico II	Naples	Campania
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli	Campania
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	Chiba cancer center	Chiba-shi	Chiba
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hiroshima City Hospital	Hiroshima
Japan	Sagara Hospital	Kagoshima
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Shinko Hospital	Kobe	Hyogo
Japan	Kumamoto Shinto General Hospital	Kumamoto
Japan	Kurume General Hospital	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Osaka International Cancer Institute	Osaka
Japan	Gunma Prefectural Cancer Center	Otashi	Gunma
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Shizuoka General Hospital	Shizuoka
Japan	Juntendo University Hospital	Tokyo
Japan	Nagano Municipal Hospital	Tomitake	Nagano
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura	Ibaraki
Japan	Tsukuba University Hospital	Tsukuba	Ibaraki
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Korea, Republic of	Dong-A University Hospital	Busan	Pusan-Kwangyokshi
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan-si	Chungcheongnam-do [Chungnam]
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Yeungnam Univeristy Medical Center	Daegu	Kyongsangbuk-do
Korea, Republic of	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Gangnam Severance Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Ajou University Hospital	Suwon-si	Kyonggi-do
Mexico	COI Centro Oncologico Internacional S.A.P.I. de C.V.	Álvaro Obregón	Distrito Federal
Mexico	Unidad de Investigación en Salud	Chihuahua
Mexico	Grupo Medico Camino Sc	Mexico City	Distrito Federal
Mexico	Filios Alta Medicina	Monterrey	Nuevo León
Mexico	Private Practice - Dr. Joaquin Reinoso	Monterrey	Nuevo León
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Unidad Médica Onco-hematológica	Puebla
Mexico	Centro Medico Zambrano Hellion	San Pedro Garza Garcia	Nuevo León
Mexico	Centro de Investigación Clínica de Alta Especialidad	Torreón	Coahuila
Netherlands	Haga Ziekenhuis locatie Leyweg	Den Haag	Zuid-Holland
Netherlands	Medische Centrum Leeuwarden	Leeuwarden	Fryslân
Netherlands	Maastricht UMC+	Maastricht	Limburg
Russian Federation	Kaluga Regional Clinical Oncology Center	Kaluga	Kalužskaja Oblast'
Russian Federation	N.N.Petrov Research Institute of Oncology	Saint Petersburg
Russian Federation	Volgograd Regional Clinical Cancer Clinic No.1	Volgograd	Volgogradskaya Oblast'
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Dexeusa	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital San Pedro de Alcántara	Cáceres	Extremadura
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida	Lleida [Lérida]
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clinico de Valencia	Valencia	Valenciana, Comunitat
Spain	Hospital Quirónsalud Valencia	Valencia	València
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Hospital - Liouying Branch	Tainan City	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center	Adana
Turkey	Ankara City Hospital	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Hacettepe Universitesi	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Sbü Gülhane Egitim Ve Arastirma Hastanesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Trakya University	Edirne
Turkey	Acibadem Maslak Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Ege Universitesi Hastanesi	Izmir
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi	Malatya
Turkey	Mersin University	Mersin
Turkey	Medipol Mega Universite Hastanesi	Stanbul	Istanbul
Turkey	Acibadem Altunizade Hospital	Üsküdar / Stanbul	Istanbul
Ukraine	CNPE "Regional Center of Oncology"	Kharkiv	Kharkivska Oblast
Ukraine	Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council	Kryvyi Rih	Dnipropetrovska Oblast
Ukraine	Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council	Lutsk	Volynska Oblast
Ukraine	Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council	Odesa	Odeska Oblast
Ukraine	Uzhgorod Central City Clinical Hospital	Uzhhorod	Zakarpatska Oblast
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Aultman Hospital	Canton	Ohio
United States	Ironwood Cancer & Research Centers	Chandler	Arizona
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Clermont Oncology Center	Clermont	Florida
United States	Care Access - Clifton	Clifton	New Jersey
United States	Minnesota Oncology/Hematology PA	Coon Rapids	Minnesota
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology Denton	Denton	Texas
United States	NorthShore University HealthSystem - Evanston Hospital	Evanston	Illinois
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Marin Cancer Care	Greenbrae	California
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Texas Oncology - Willowbrook	Houston	Texas
United States	Willamette Valley Cancer Institute & Research Ctr.	Houston	Texas
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	The University of Louisville, James Graham Brown Cancer Center	Louisville	Kentucky
United States	Banner MD Anderson Cancer Center at McKee Medical Center	Loveland	Colorado
United States	Memorial Sloan Kettering - Bergen	Montvale	New Jersey
United States	IU Health Ball Memorial Hospital, Inc.	Muncie	Indiana
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mid Florida Hematology and Oncology Center	Orange City	Florida
United States	University of California Davis (UC Davis) Comprehensive Cancer Center	Sacramento	California
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Florida Cancer Specialists	Sarasota	Florida
United States	Avera Cancer Institute Sioux Falls	Sioux Falls	South Dakota
United States	Broome Oncology	The Woodlands	Texas
United States	Texas Oncology - Denison	The Woodlands	Texas
United States	Texas Oncology - McKinney	The Woodlands	Texas
United States	Texas Oncology - San Antonio Medical Center	The Woodlands	Texas
United States	Texas Oncology - The Woodlands	The Woodlands	Texas
United States	Texas Oncology Denton	The Woodlands	Texas
United States	Texas Oncology Fort Worth	The Woodlands	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	The Woodlands	Texas
United States	US Oncology	The Woodlands	Texas
United States	Mercy Health - St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  Czechia,  France,  Germany,  Greece,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population	PFS by investigator assessment in the IIT population	Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Primary	PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population	PFS by investigator assessment in ESR1-mutation detected population	Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Secondary	Overall Survival (OS) in the IIT Population	OS in the IIT population	Randomization until death from any cause (estimated as up to 5 years)
Secondary	OS in the ESR1-mutation Detected Population	OS in the ESR1-mutation detected population	Randomization until death from any cause (estimated as up to 5 years)
Secondary	Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)	ORR	Randomization until measured progressive disease (estimated as up to 1 year)
Secondary	Duration of Response (DoR)	DoR	Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Secondary	Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (=) 24 Weeks	CBR	Randomization until measured progressive disease (estimated as up to 1 year)
Secondary	Progression Free Survival (PFS)	PFS by blinded independent review	Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Secondary	Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"	Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."	Screening through follow-up (estimated as up to 3 years)
Secondary	Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant	PK: steady state plasma concentrations of imlunestrant	Cycle 2 to Cycle 4 (cycle = 28 days)
Secondary	PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib	PK: steady state plasma concentrations of imlunestrant and abemaciclib	Cycle 2 to Cycle 4 (cycle = 28 days)

External Links

•   Study of LY3484356 Versus Hormone Therapy, in Participants With Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer (EMBER-3)