Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)
24 de junio de 2026 actualizado por: iOMEDICO AG
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
500
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Laura Serrer
- Número de teléfono: +49761152420
- Correo electrónico: eleni@iomedico.com
Ubicaciones de estudio
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Freiburg im Breisgau, Alemania, 79110
- Reclutamiento
- Praxis für interdisziplinäre Onkologie & Hämatologie
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Contacto:
- Patrick Marschner
- Número de teléfono: +49761386870
- Correo electrónico: klifo@onkologie-freiburg.de
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Paderborn, Alemania, 33098
- Reclutamiento
- St. Louise Frauen- und Kinderklinik
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Contacto:
- Michael P Lux
- Número de teléfono: +49 5251864121
- Correo electrónico: M.Lux@vincenz.de
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Ravensburg, Alemania, 88212
- Reclutamiento
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Contacto:
- Thomas Decker
- Número de teléfono: +49 751 366197-0
- Correo electrónico: thomas.decker@onkonet.eu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
Postmenopausal women with locally advanced and/or metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2)- breast cancer with disease progression on endocrine therapy and cyclin-dependent kinase inhibitor (CDKi) and intention for second line (2L) treatment with elacestrant according to summary of product characteristics (SmPC).
Descripción
Inclusion Criteria:
- Signed and dated informed consent form
- Postmenopausal women
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- Locally advanced and/or metastatic ER+ HER2- breast cancer
- Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC))
- Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score)
- Disease progression following first line ET + CDKi
- No more than one prior ET line in the advanced/metastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion)
- For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment
Exclusion Criteria
- Prior chemotherapy in the advanced/metastatic setting
- Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.
- Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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ESR1 wildtype
Patients with a ESR1 wildtype tumor
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Treatment decision of investigator
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ESR1 mutated
Patients with a ESR1 mutated tumor
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According to the Summary of Product Characteristics (SmPC)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in EORTC global health scale
Periodo de tiempo: From Time of enrollment until month 11
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Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
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From Time of enrollment until month 11
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluar los parámetros de la toma de decisiones de tratamiento de los médicos mediante un cuestionario.
Periodo de tiempo: Base
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Frecuencia de distintos parámetros que afectan la elección de la terapia; Cuestionario completado por el médico tratante.
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Base
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Time to deterioration in global health scale (EORTC QLQ-C30)
Periodo de tiempo: From Time of enrollment until month 11
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Time to deterioration in global health scale of EORTC QLQ-C30 The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
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From Time of enrollment until month 11
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Time to deterioration in functional scores (EORTC QLQ-C30)
Periodo de tiempo: From Time of enrollment until month 11
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Time to deterioration in functional scores of EORTC QLQ-C30.
The EORTC QLQ- C30 functional score ranges from 0 to 100, with higher scores indicating better quality of life.
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From Time of enrollment until month 11
|
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Time to deterioration in symptom scores (EORTC QLQ-C30)
Periodo de tiempo: From Time of enrollment until month 11
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Time to deterioration in symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 symptom score ranges from 0 to 100, with lower scores indicating better quality of life.
|
From Time of enrollment until month 11
|
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Change from baseline in functional and symptom scores
Periodo de tiempo: From Time of enrolment until up to 11 months after enrolment.
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Change from baseline in functional and symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 functional and symptom scores ranges from 0 to 100, with higher scores indicating better quality of life (for functional scores), and lower indication better quality of life for symptom scores.
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From Time of enrolment until up to 11 months after enrolment.
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Change from baseline in visual analogue scale (VAS)
Periodo de tiempo: From Time of enrollment until month 11.
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Change from baseline in EQ-5D-5L visual analogue scale (VAS); The EQ-5D-5L VAS ranges from 0 to 100, with higher scores indicating better quality of life.
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From Time of enrollment until month 11.
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Change from baseline in index value
Periodo de tiempo: From Time of enrollment until month 11.
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Change from baseline in EQ-5D-5L Index Value The EQ-5D-5L index value ranges from -0.661 to 1, with higher scores indicating better quality of life.
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From Time of enrollment until month 11.
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Change from baseline in all scales of EQ-5D-5L
Periodo de tiempo: From Time of enrollment until month 11.
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Change from baseline in all scales of EQ-5D-5L The scales of EQ-5D-5L range from 1 to 5, with lower scores indicating better quality of life.
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From Time of enrollment until month 11.
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Prevalence of ESR1 mutation
Periodo de tiempo: Baseline
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Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.
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Baseline
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Drug safety: Frequency
Periodo de tiempo: From time of treatment start until 30 days after end of elacestrant treatment
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Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)
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From time of treatment start until 30 days after end of elacestrant treatment
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Drug safety: Incidence of adverse events
Periodo de tiempo: From time of treatment start until 30 days after end of elacestrant treatment
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Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)
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From time of treatment start until 30 days after end of elacestrant treatment
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Drug safety: Change from baseline in AST (Aspartate Aminotransferase)
Periodo de tiempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in AST
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
Periodo de tiempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in ALT
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Drug safety: Change from baseline in bilirubin
Periodo de tiempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in bilirubin
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Patients and disease characteristics: Age
Periodo de tiempo: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (</≥ 65))
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Baseline
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Patients and disease characteristics: Body mass index (BMI)
Periodo de tiempo: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))
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Baseline
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Patients and disease characteristics: ECOG Performance status
Periodo de tiempo: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status
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Baseline
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Patients and disease characteristics: CCI (Charlson score and contributing diseases)
Periodo de tiempo: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
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Baseline
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Patients and disease characteristics: Time since diagnosis
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
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Baseline
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Patients and disease characteristics: TNM staging
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
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Baseline
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Patients and disease characteristics: Metastatic sites
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
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Baseline
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Patients and disease characteristics: Tumor Grading
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion
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Baseline
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Patients and disease characteristics: HR and HER2 status
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion
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Baseline
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Patients and disease characteristics: Prior adjuvant chemotherapy
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
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Baseline
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Patients and disease characteristics: Prior adjuvant endocrine therapy
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy
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Baseline
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Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Type and duration of prior CDKi/endocrine therapy in the palliative setting (descriptive statistics, categorical ≤6 months / >6 months; ≤12 months / >12 months)
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Baseline
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Patients and disease characteristics: Disease site
Periodo de tiempo: At time of enrollment
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Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion
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At time of enrollment
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Patients and disease characteristics: concomitant diseases
Periodo de tiempo: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
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Baseline
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Use of concomitant medication
Periodo de tiempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess the use of concomitant medication during treatment with elacestrant.
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment
Periodo de tiempo: max. 24 months; at patient patient-specific start of treatment
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Assess second-line treatments for all patients by ESR1 status (Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment (refers to first treatment received starting from second line)
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max. 24 months; at patient patient-specific start of treatment
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Details on treatment with elacestrant: reason for end of treatment
Periodo de tiempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess reason for end of treatment (treatment with elacestrant)
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: dose intensity
Periodo de tiempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: frequency and type of dose modification
Periodo de tiempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: reasons for dose modifications and interruptions
Periodo de tiempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess reasons for dose modifications and interruptions (elacestrant treatment)
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
Periodo de tiempo: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)
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max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
Periodo de tiempo: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Details on treatments following elacestrant therapy:Frequency of first subsequent systemic antineoplastic therapy for ESR1mut patients (refers to first treatment received after Elacestrant so starting from third line)
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max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas Decker, Professor, Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- Investigador principal: Michael Patrick Lux, Professor, St. Louise Frauen- und Kinderklinik Paderborn
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2028
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
2 de diciembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
- elacestrante
Otros números de identificación del estudio
- IOM-090506
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .