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

29. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

500

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Německo
      • Paderborn, Německo, 33098
        • St. Louise Frauen- und Kinderklinik
        • Kontakt:
      • Ravensburg, Německo, 88212
        • Gemeinschaftspraxis Fur Hamatologie Und Onkologie
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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).

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
ESR1 wildtype
Patients with a ESR1 wildtype tumor
Lék: Standard of care (Investigator Choice)
Treatment decision of investigator
ESR1 mutated
Patients with a ESR1 mutated tumor
Lék: Elacestrant
According to the Summary of Product Characteristics (SmPC)
Ostatní jména:
  • Orserdu®

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in EORTC global health scale
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hodnotit parametry rozhodování lékařů o léčbě pomocí dotazníku
Časové okno: Základní linie
Frekvence různých parametrů ovlivňujících volbu terapie; dotazník vyplněný ošetřujícím lékařem.
Základní linie
Time to deterioration in global health scale (EORTC QLQ-C30)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Baseline
Patients and disease characteristics: TNM staging
Časové okno: 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
Časové okno: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Baseline
Patients and disease characteristics: Tumor Grading
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Baseline
Use of concomitant medication
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

iOMEDICO AG

Spolupracovníci

Berlin Chemie AG

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

1. května 2028

Dokončení studie (Odhadovaný)

1. července 2029

Termíny zápisu do studia

První předloženo

2. prosince 2025

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IOM-090506

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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