Last updated 56 days ago
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
6000 patients around the world
Available in Argentina, Mexico, United States, Brazil, Spain
Eli Lilly and Company
76Research sites
6000Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.Must have an increased risk of disease recurrence based on clinical-pathological risk features.Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.Have adequate organ function.
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.Participants with a history of any other cancer.Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Instituto San Marcos Investigación - San Juan
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
Go Centro Médico San Nicolás
Recruiting
StudyEMBER-4
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05514054
