A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Phase 3 – large-scale trial before approval
Conditions:
Breast Neoplasms
Neoplasm Metastasis
Sponsor: Eli Lilly and Company
trial.available_in:
БГ
Overview
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.
Who can participate
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
Locations
21
Argentina (1)
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata , Buenos Aires
Australia (1)
St Vincent's Hospital
Darlinghurst , New South Wales
Belgium (1)
Imelda General Hospital
Bonheiden , Antwerpen
Brazil (1)
Hospital de Cancer de Londrina
Londrina , Paraná
China (1)
Afflilated Hospital of Bengbu Medical College
Bengbu , Anhui
Czech Republic (1)
Nemocnice Horovice
Hořovice , Beroun
France (1)
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg , Alsace
Germany (1)
Klinikum Ludwigsburg
Ludwigsburg , Baden-Wurttemberg
Greece (1)
Agios Savvas Regional Cancer Hospital
Athens , Attikí
India (1)
Medstar Speciality Hospital
Bangalore , Karnataka
Italy (1)
University of Naples Federico II
Naples , Campania
Japan (1)
Nagoya University Hospital
Nagoya , Aichi-ken
Mexico (1)
Centro de Investigación Clínica de Alta Especialidad
Torreón , Coahuila
Netherlands (1)
Maastricht UMC+
Maastricht , Limburg
Russia (1)
Kaluga Regional Clinical Oncology Center
Kaluga , Kalužskaja Oblast'
South Korea (1)
Soon Chun Hyang University Cheonan Hospital
Cheonan-si , Chungcheongnam-do [Chungnam]
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [Barcelona]
Taiwan (1)
Chi Mei Hospital - Liouying Branch
Tainan , Tainan
Turkey (1)
Medipol University Medical Faculty
Stanbul , Istanbul
Ukraine (1)
Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council