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

29. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
      • Paderborn, Tyskland, 33098
        • St. Louise Frauen- und Kinderklinik
        • Kontakt:
      • Ravensburg, Tyskland, 88212
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ESR1 wildtype
Patients with a ESR1 wildtype tumor
Medicin: Standard of care (Investigator Choice)
Treatment decision of investigator
ESR1 mutated
Patients with a ESR1 mutated tumor
Medicin: Elacestrant
According to the Summary of Product Characteristics (SmPC)
Andre navne:
  • Orserdu®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in EORTC global health scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vurder parametre for lægers behandlingsbeslutninger ved hjælp af et spørgeskema
Tidsramme: Baseline
Hyppighed af forskellige parametre, der påvirker terapivalg; spørgeskema udfyldt af behandlende læge.
Baseline
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
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
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
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.
From Time of enrolment until up to 11 months after enrolment.
Change from baseline in visual analogue scale (VAS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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)
From time of treatment start until 30 days after end of elacestrant treatment
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)
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Baseline
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
Patients and disease characteristics: Metastatic sites
Tidsramme: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Baseline
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
Baseline
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
Baseline
Patients and disease characteristics: Prior adjuvant chemotherapy
Tidsramme: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Baseline
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
Baseline
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)
Baseline
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
At time of enrollment
Patients and disease characteristics: concomitant diseases
Tidsramme: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Baseline
Use of concomitant medication
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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)
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

iOMEDICO AG

Samarbejdspartnere

Berlin Chemie AG

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

2. december 2025

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IOM-090506

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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