Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06492616Tipo: INTERVENTIONALInicio: 27 de sept de 2024Fin estimado: 1 de oct de 2032

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Participants considered at high risk of recurrence at initial staging
Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Criterios de exclusión

Participants with inflammatory breast cancer
History of any prior (ipsilateral and/or contralateral) invasive breast cancer
Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization

Intervenciones

drug

Elacestrant

Administered as oral tablets

drug

Anastrozole

Administered as oral tablets

drug

Letrozole

Administered as oral tablets

drug

Exemestane

Administered as oral tablets

drug

Tamoxifen

Administered as oral tablets

Ubicaciones

(COIBA)Centro de Oncologia e Investigacion Buenos Aires

Berazategui, Buenos Aires, Argentina

Gladis Paz

RECRUITING

Fundacion Respirar

Buenos Aires, Buenos Aires F.D., Argentina

Christian Fuentes

RECRUITING

Organizacion Medica de Investigacion (OMI)

Buenos Aires, Buenos Aires F.D., Argentina

Margarita Sonia Alfie

RECRUITING

Centro de Investigación CIPREC

C.a.b.a., Buenos Aires F.D., Argentina

Ezequiel Slutsky

RECRUITING

Centro Oncológico Korben

CABA, Buenos Aires F.D., Argentina

Ernesto Korbenfeld

RECRUITING

Centro Medico Privado CEMAIC

Córdoba, Córdoba Province, Argentina

Jorge Salinas

RECRUITING

Inst Med Fund Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Gabriel Garbaos

RECRUITING

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Cristian Micheri

RECRUITING

Clinica Adventista Belgrano

Buenos Aires, Tucumán Province, Argentina

Guido Garozzo

RECRUITING

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Juan Cundom

RECRUITING

Centro Oncologico de Excelencia

San Juan, Argentina

Juan Puig

RECRUITING

Patrocinadores

PrincipalStemline Therapeutics, Inc.

Contactos

Stemline Trials

CONTACT

clinicaltrials@menarinistemline.com 1-877-332-7961

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.

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