Last updated 2 months 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
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Monseñor Pablo Cabrera 2941, Córdoba
Instituto San Marcos Investigación - San Juan
Instituto San Marcos Investigación - San Juan
Recruiting
Sarmiento 92 norte, San Juan
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
25 de mayo 174, Viedma, Río Negro
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Laprida 532 Este, San Juan
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Av. Pueyrredon 1746, CABA, Buenos Aires
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Dorrego 269, La Rioja
Clínica Adventista Belgrano - CABA - Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Estomba 1710, CABA, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Av. Colón 3456, Mar del Plata, Buenos Aires
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
Calle 12 Nro 4756, Berazategui, Buenos Aires
Go Centro Médico San Nicolás
Recruiting
San Nicolás, Buenos Aires, Argentina, 2900
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