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

keskiviikko 24. kesäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

500

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Saksa
      • Freiburg im Breisgau, Saksa, 79110
        • Rekrytointi
        • Praxis für interdisziplinäre Onkologie & Hämatologie
        • Ottaa yhteyttä:
      • Paderborn, Saksa, 33098
        • Rekrytointi
        • St. Louise Frauen- und Kinderklinik
        • Ottaa yhteyttä:
      • Ravensburg, Saksa, 88212
        • Rekrytointi
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

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).

Kuvaus

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)

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
ESR1 wildtype
Patients with a ESR1 wildtype tumor
Lääke: Standard of care (Investigator Choice)
Treatment decision of investigator
ESR1 mutated
Patients with a ESR1 mutated tumor
Lääke: Elacestrant
According to the Summary of Product Characteristics (SmPC)
Muut nimet:
  • Orserdu®

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change from baseline in EORTC global health scale
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Arvioi lääkäreiden hoitopäätöksen parametrit kyselylomakkeella
Aikaikkuna: Perustaso
Erillisten parametrien esiintymistiheys, jotka vaikuttavat hoidon valintaan; hoitavan lääkärin täyttämä kyselylomake.
Perustaso
Time to deterioration in global health scale (EORTC QLQ-C30)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Baseline
Patients and disease characteristics: TNM staging
Aikaikkuna: 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
Aikaikkuna: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Baseline
Patients and disease characteristics: Tumor Grading
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Baseline
Use of concomitant medication
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

iOMEDICO AG

Yhteistyökumppanit

Berlin Chemie AG

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 19. kesäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Torstai 1. kesäkuuta 2028

Opintojen valmistuminen (Arvioitu)

Torstai 1. kesäkuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 2. joulukuuta 2025

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 29. huhtikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 4. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 25. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 24. kesäkuuta 2026

Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • IOM-090506

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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