A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)
Breast Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring SERD
Eligibility Criteria
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
Sites / Locations
- Banner MD Anderson Cancer CenterRecruiting
- Marin Cancer CareRecruiting
- University of California Davis (UC Davis) Comprehensive Cancer CenterRecruiting
- Banner MD Anderson Cancer Center at North Colorado Medical CenterRecruiting
- Rocky Mountain Cancer CenterRecruiting
- Banner MD Anderson Cancer Center at McKee Medical CenterRecruiting
- Clermont Oncology CenterRecruiting
- University of Florida College of MedicineRecruiting
- Mid Florida Hematology and Oncology CenterRecruiting
- Florida Cancer SpecialistsRecruiting
- Florida Cancer SpecialistsRecruiting
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Minnesota Oncology/Hematology PARecruiting
- Jackson Oncology Associates, PLLCRecruiting
- Care Access - CliftonRecruiting
- Memorial Sloan Kettering - BergenRecruiting
- Aultman HospitalRecruiting
- The Mark H Zangmeister Cancer CenterRecruiting
- Mercy Health - St. Vincent Medical CenterRecruiting
- Willamette Valley Cancer Institute & Research Ctr.Recruiting
- Avera Cancer Institute Sioux FallsRecruiting
- Texas Oncology - Austin CentralRecruiting
- Texas Oncology - CarrolltonRecruiting
- Texas Oncology - Methodist Charlton Cancer CenterRecruiting
- Texas Oncology - Medical City DallasRecruiting
- Texas Oncology - Dallas Presbyterian HospitalRecruiting
- Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
- Texas Oncology - DenisonRecruiting
- Texas Oncology DentonRecruiting
- Texas Oncology Fort WorthRecruiting
- Texas Oncology - WillowbrookRecruiting
- Texas Oncology - McKinneyRecruiting
- Texas Oncology - ParisRecruiting
- Texas Oncology - San Antonio Medical CenterRecruiting
- Texas Oncology - The WoodlandsRecruiting
- US OncologyRecruiting
- Utah Cancer Specialists
- The University of Vermont Medical Center Inc.Recruiting
- Blue Ridge Cancer CareRecruiting
- Instituto de Investigaciones Clínicas Mar del PlataRecruiting
- Fundación Cenit Para La Investigación En NeurocienciasRecruiting
- Centro Medico Privado CEMAICRecruiting
- Clinica ViedmaRecruiting
- Instituto Argentino de Diagnóstico y Tratamiento (IADT)Recruiting
- Instituto San MarcosRecruiting
- Cancer Research SARecruiting
- Maroondah HospitalRecruiting
- Private Practice - Dr. HubalekRecruiting
- Uniklinikum Salzburg, Universitaetsklinik für Innere Medizin III der PMURecruiting
- Imelda General HospitalRecruiting
- Institut Jules BordetRecruiting
- AZ NikolaasRecruiting
- CHU UCL Namur/Site Sainte ElisabethRecruiting
- Hospital de Cancer de Londrina
- Icesp - Instituto Do Câncer Do Estado de São PauloRecruiting
- Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDARecruiting
- Beijing HospitalRecruiting
- Beijing Cancer hospital
- The Third Hospital of NanchangRecruiting
- The Second Hospital of Jilin UniversityRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Jining Medical University - Affiliated HospitalRecruiting
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- The First Affiliated Hospital, Zhejiang University
- Sir Run Run Shaw HospitalRecruiting
- Ningbo Medical CenterRecruiting
- Institut de cancérologie Strasbourg Europe (ICANS)Recruiting
- Polyclinique De BloisRecruiting
- Institut Curie - site Saint-CloudRecruiting
- Centre de Cancérologie du Grand MontpellierRecruiting
- Institut CurieRecruiting
- Institut de Cancérologie de Lorraine Alexis VautrinRecruiting
- Onkologische Schwerpunktpraxis Heidelberg, Dr. med. Andreas Karcher, Dr. med. Daniel Debatin, Dr. med. Stefan FuxiusRecruiting
- Onkologiezentrum DonauwörthRecruiting
- Gynäkologisch-Onkologische Praxis am PelikanplatzRecruiting
- Gynaekologisches Zentrum BonnRecruiting
- General Oncology Hospital of Kifissia "Agioi Anargiroi"Recruiting
- European Interbalkan Medical CenterRecruiting
- Medstar Speciality HospitalRecruiting
- Regional Cancer Centre - ThiruvananthapuramRecruiting
- Deenanath Mangeshkar Hospital & Research CentreRecruiting
- Lifepoint Multispeciality HospitalRecruiting
- Yashoda HospitalsRecruiting
- Nagoya University HospitalRecruiting
- Chiba cancer centerRecruiting
- Kurume General HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
- Niigata Cancer Center HospitalRecruiting
- National Hospital Organization Hokkaido Cancer CenterRecruiting
- Hyogo Cancer CenterRecruiting
- Shinko HospitalRecruiting
- Tsuchiura Kyodo General HospitalRecruiting
- Tsukuba University HospitalRecruiting
- St. Marianna University HospitalRecruiting
- Hikita Pediatric clinicRecruiting
- Showa University HospitalRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Hiroshima City HospitalRecruiting
- Kumamoto Shinto General HospitalRecruiting
- Osaka International Cancer InstituteRecruiting
- Shizuoka General HospitalRecruiting
- Juntendo University HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Yeungnam Univeristy Medical CenterRecruiting
- Kangbuk Samsung HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Centro de Investigación Clínica de Alta EspecialidadRecruiting
- Private Practice - Dr. Joaquin ReinosoRecruiting
- Filios Alta MedicinaRecruiting
- Centro Medico Zambrano HellionRecruiting
- Unidad de Investigación en SaludRecruiting
- Oaxaca Site Management OrganizationRecruiting
- Unidad Médica Onco-hematológicaRecruiting
- Maastricht UMC+Recruiting
- Volgograd Regional Clinical Cancer Clinic No.1Recruiting
- N.N.Petrov Research Institute of OncologyRecruiting
- Hospital Universitari DexeusaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital San Pedro de AlcántaraRecruiting
- Hospital Universitario San CecilioRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Chi Mei Hospital - Liouying BranchRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
- Taichung Veterans General HospitalRecruiting
- Medipol Mega Universite HastanesiRecruiting
- Baskent University Dr. Turgut Noyan Research and Training CenterRecruiting
- Acıbadem Maslak HastanesiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Imlunestrant
Investigator's Choice of Endocrine Therapy
Imlunestrant plus Abemaciclib
Imlunestrant administered orally.
Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.
Imlunestrant plus abemaciclib administered orally.