postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05169567Tipo: INTERVENTIONALInicio: 11 de mar de 2022Fin estimado: 1 de dic de 2027

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have radiologic evidence of disease progression or recurrence either
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable 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 visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Have symptomatic or untreated central nervous system metastasis
Have received any systemic therapy between disease recurrence/progression and study screening
Have received more than 1 line of therapy for advanced or metastatic disease.
Have received prior chemotherapy for metastatic breast cancer (MBC)
Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders \[SERDs\] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor

Intervenciones

drug

Abemaciclib

Administered orally.

drug

Fulvestrant

Administered IM.

drug

Placebo

Administered orally.

Ubicaciones

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., Argentina

Fundación Respirar

Buenos Aires, Buenos Air, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

CER San Juan

San Juan, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

postMONARCH: A Randomized, Double Blind, Placebo-Controll... | EligiMed