Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)
24. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
500
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Laura Serrer
- Telefonnummer: +49761152420
- E-post: eleni@iomedico.com
Studiesteder
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Freiburg im Breisgau, Tyskland, 79110
- Rekruttering
- Praxis für interdisziplinäre Onkologie & Hämatologie
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Ta kontakt med:
- Patrick Marschner
- Telefonnummer: +49761386870
- E-post: klifo@onkologie-freiburg.de
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Paderborn, Tyskland, 33098
- Rekruttering
- St. Louise Frauen- und Kinderklinik
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Ta kontakt med:
- Michael P Lux
- Telefonnummer: +49 5251864121
- E-post: M.Lux@vincenz.de
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Ravensburg, Tyskland, 88212
- Rekruttering
- Gemeinschaftspraxis für Hämatologie und Onkologie
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Ta kontakt med:
- Thomas Decker
- Telefonnummer: +49 751 366197-0
- E-post: thomas.decker@onkonet.eu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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).
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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)
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in EORTC global health scale
Tidsramme: 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.
|
From Time of enrollment until month 11
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Vurder parametere for legers behandlingsbeslutninger ved hjelp av et spørreskjema
Tidsramme: Grunnlinje
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Frekvens av distinkte parametere som påvirker terapivalg; spørreskjema utfylt av behandlende lege.
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Grunnlinje
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Time to deterioration in global health scale (EORTC QLQ-C30)
Tidsramme: 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
|
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Time to deterioration in functional scores (EORTC QLQ-C30)
Tidsramme: 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
|
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Time to deterioration in symptom scores (EORTC QLQ-C30)
Tidsramme: 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
|
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Change from baseline in functional and symptom scores
Tidsramme: 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.
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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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
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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)
Tidsramme: 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)
Tidsramme: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
|
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
Tidsramme: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
|
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
Tidsramme: Baseline
|
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)
Tidsramme: Baseline
|
Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))
|
Baseline
|
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Patients and disease characteristics: ECOG Performance status
Tidsramme: Baseline
|
Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status
|
Baseline
|
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Patients and disease characteristics: CCI (Charlson score and contributing diseases)
Tidsramme: Baseline
|
Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
|
Baseline
|
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Patients and disease characteristics: Time since diagnosis
Tidsramme: Baseline
|
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
Tidsramme: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
|
Baseline
|
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Patients and disease characteristics: Metastatic sites
Tidsramme: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
|
Baseline
|
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Patients and disease characteristics: Tumor Grading
Tidsramme: Baseline
|
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
Tidsramme: Baseline
|
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
Tidsramme: Baseline
|
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
Tidsramme: Baseline
|
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
Tidsramme: 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)
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Baseline
|
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Patients and disease characteristics: Disease site
Tidsramme: 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
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At time of enrollment
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Patients and disease characteristics: concomitant diseases
Tidsramme: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
|
Baseline
|
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Use of concomitant medication
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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
Tidsramme: 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
Tidsramme: 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)
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Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
Tidsramme: 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
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Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas Decker, Professor, Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- Hovedetterforsker: Michael Patrick Lux, Professor, St. Louise Frauen- und Kinderklinik Paderborn
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. juni 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. juni 2028
Datoer for studieregistrering
Først innsendt
2. desember 2025
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IOM-090506
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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