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Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Germania
      • Freiburg im Breisgau, Germania, 79110
        • Reclutamento
        • Praxis für interdisziplinäre Onkologie & Hämatologie
        • Contatto:
      • Paderborn, Germania, 33098
        • Reclutamento
        • St. Louise Frauen- und Kinderklinik
        • Contatto:
      • Ravensburg, Germania, 88212
        • Reclutamento
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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).

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
ESR1 wildtype
Patients with a ESR1 wildtype tumor
Droga: Standard of care (Investigator Choice)
Treatment decision of investigator
ESR1 mutated
Patients with a ESR1 mutated tumor
Droga: Elacestrant
According to the Summary of Product Characteristics (SmPC)
Altri nomi:
  • Orserdu®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in EORTC global health scale
Lasso di tempo: From Time of enrollment until month 11
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.
From Time of enrollment until month 11

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Valutare i parametri del processo decisionale terapeutico da parte dei medici utilizzando un questionario
Lasso di tempo: Linea di base
Frequenza di parametri distinti che influenzano la scelta della terapia; questionario compilato dal medico curante.
Linea di base
Time to deterioration in global health scale (EORTC QLQ-C30)
Lasso di tempo: From Time of enrollment until month 11
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.
From Time of enrollment until month 11
Time to deterioration in functional scores (EORTC QLQ-C30)
Lasso di tempo: From Time of enrollment until month 11
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.
From Time of enrollment until month 11
Time to deterioration in symptom scores (EORTC QLQ-C30)
Lasso di tempo: From Time of enrollment until month 11
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
Change from baseline in functional and symptom scores
Lasso di tempo: From Time of enrolment until up to 11 months after enrolment.
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.
From Time of enrolment until up to 11 months after enrolment.
Change from baseline in visual analogue scale (VAS)
Lasso di tempo: From Time of enrollment until month 11.
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.
From Time of enrollment until month 11.
Change from baseline in index value
Lasso di tempo: From Time of enrollment until month 11.
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.
From Time of enrollment until month 11.
Change from baseline in all scales of EQ-5D-5L
Lasso di tempo: From Time of enrollment until month 11.
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.
From Time of enrollment until month 11.
Prevalence of ESR1 mutation
Lasso di tempo: Baseline
Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.
Baseline
Drug safety: Frequency
Lasso di tempo: From time of treatment start until 30 days after end of elacestrant treatment
Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)
From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Incidence of adverse events
Lasso di tempo: From time of treatment start until 30 days after end of elacestrant treatment
Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)
From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Change from baseline in AST (Aspartate Aminotransferase)
Lasso di tempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Change from baseline in AST
From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
Lasso di tempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Change from baseline in ALT
From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in bilirubin
Lasso di tempo: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Change from baseline in bilirubin
From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Patients and disease characteristics: Age
Lasso di tempo: Baseline
Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (</≥ 65))
Baseline
Patients and disease characteristics: Body mass index (BMI)
Lasso di tempo: Baseline
Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))
Baseline
Patients and disease characteristics: ECOG Performance status
Lasso di tempo: Baseline
Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status
Baseline
Patients and disease characteristics: CCI (Charlson score and contributing diseases)
Lasso di tempo: Baseline
Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
Baseline
Patients and disease characteristics: Time since diagnosis
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Baseline
Patients and disease characteristics: TNM staging
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
Baseline
Patients and disease characteristics: Metastatic sites
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Baseline
Patients and disease characteristics: Tumor Grading
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion
Baseline
Patients and disease characteristics: HR and HER2 status
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion
Baseline
Patients and disease characteristics: Prior adjuvant chemotherapy
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy
Baseline
Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting
Lasso di tempo: Baseline
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)
Baseline
Patients and disease characteristics: Disease site
Lasso di tempo: At time of enrollment
Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion
At time of enrollment
Patients and disease characteristics: concomitant diseases
Lasso di tempo: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Baseline
Use of concomitant medication
Lasso di tempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess the use of concomitant medication during treatment with elacestrant.
max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment
Lasso di tempo: max. 24 months; at patient patient-specific start of treatment
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)
max. 24 months; at patient patient-specific start of treatment
Details on treatment with elacestrant: reason for end of treatment
Lasso di tempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess reason for end of treatment (treatment with elacestrant)
max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: dose intensity
Lasso di tempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician
max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: frequency and type of dose modification
Lasso di tempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.
max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: reasons for dose modifications and interruptions
Lasso di tempo: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess reasons for dose modifications and interruptions (elacestrant treatment)
max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
Lasso di tempo: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)
max. 24 months; from the patient-specific end of elacestrant treatment until end of study
Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
Lasso di tempo: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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)
max. 24 months; from the patient-specific end of elacestrant treatment until end of study

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

iOMEDICO AG

Collaboratori

Berlin Chemie AG

Investigatori

  • Investigatore principale: Thomas Decker, Professor, Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
  • Investigatore principale: Michael Patrick Lux, Professor, St. Louise Frauen- und Kinderklinik Paderborn

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 giugno 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

2 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IOM-090506

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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