Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)
24 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
500
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Laura Serrer
- Telefoonnummer: +49761152420
- E-mail: eleni@iomedico.com
Studie Locaties
-
-
-
Freiburg im Breisgau, Duitsland, 79110
- Werving
- Praxis für interdisziplinäre Onkologie & Hämatologie
-
Contact:
- Patrick Marschner
- Telefoonnummer: +49761386870
- E-mail: klifo@onkologie-freiburg.de
-
Paderborn, Duitsland, 33098
- Werving
- St. Louise Frauen- und Kinderklinik
-
Contact:
- Michael P Lux
- Telefoonnummer: +49 5251864121
- E-mail: M.Lux@vincenz.de
-
Ravensburg, Duitsland, 88212
- Werving
- Gemeinschaftspraxis für Hämatologie und Onkologie
-
Contact:
- Thomas Decker
- Telefoonnummer: +49 751 366197-0
- E-mail: thomas.decker@onkonet.eu
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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).
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
ESR1 wildtype
Patients with a ESR1 wildtype tumor
|
Treatment decision of investigator
|
|
ESR1 mutated
Patients with a ESR1 mutated tumor
|
According to the Summary of Product Characteristics (SmPC)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in EORTC global health scale
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Beoordeel de parameters van de behandelbeslissingen van artsen met behulp van een vragenlijst
Tijdsspanne: Basislijn
|
Frequentie van verschillende parameters die de therapiekeuze beïnvloeden; vragenlijst ingevuld door de behandelend arts.
|
Basislijn
|
|
Time to deterioration in global health scale (EORTC QLQ-C30)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
|
Baseline
|
|
Patients and disease characteristics: TNM staging
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
|
Baseline
|
|
Patients and disease characteristics: Tumor Grading
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
|
Baseline
|
|
Patients and disease characteristics: Prior adjuvant endocrine therapy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
|
Baseline
|
|
Use of concomitant medication
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Thomas Decker, Professor, Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- Hoofdonderzoeker: Michael Patrick Lux, Professor, St. Louise Frauen- und Kinderklinik Paderborn
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 juni 2026
Primaire voltooiing (Geschat)
1 juni 2028
Studie voltooiing (Geschat)
1 juni 2028
Studieregistratiedata
Eerst ingediend
2 december 2025
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
4 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IOM-090506
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .