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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04975308Tipo: INTERVENTIONALInicio: 4 de oct de 2021Fin estimado: 1 de ago de 2027

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Imlunestrant

Administered orally.

drug

Exemestane

Administered orally.

drug

Fulvestrant

Administered IM.

drug

Abemaciclib

Administered orally.

Ubicaciones

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT)

Buenos Aires, Argentina

Instituto San Marcos

San Juan, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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