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

24 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

500

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Niemcy
      • Freiburg im Breisgau, Niemcy, 79110
        • Rekrutacyjny
        • Praxis für interdisziplinäre Onkologie & Hämatologie
        • Kontakt:
      • Paderborn, Niemcy, 33098
        • Rekrutacyjny
        • St. Louise Frauen- und Kinderklinik
        • Kontakt:
      • Ravensburg, Niemcy, 88212
        • Rekrutacyjny
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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).

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
ESR1 wildtype
Patients with a ESR1 wildtype tumor
Lek: Standard of care (Investigator Choice)
Treatment decision of investigator
ESR1 mutated
Patients with a ESR1 mutated tumor
Lek: Elacestrant
According to the Summary of Product Characteristics (SmPC)
Inne nazwy:
  • Orserdu®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in EORTC global health scale
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Ocenić parametry podejmowania decyzji terapeutycznych przez lekarzy za pomocą kwestionariusza
Ramy czasowe: Linia bazowa
Częstotliwość różnych parametrów wpływających na wybór terapii; kwestionariusz wypełniany przez lekarza prowadzącego.
Linia bazowa
Time to deterioration in global health scale (EORTC QLQ-C30)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Baseline
Patients and disease characteristics: TNM staging
Ramy czasowe: 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
Ramy czasowe: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Baseline
Patients and disease characteristics: Tumor Grading
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Baseline
Use of concomitant medication
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

iOMEDICO AG

Współpracownicy

Berlin Chemie AG

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

2 grudnia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IOM-090506

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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