Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)
2026년 6월 24일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
500
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Laura Serrer
- 전화번호: +49761152420
- 이메일: eleni@iomedico.com
연구 장소
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Freiburg im Breisgau, 독일, 79110
- 모병
- Praxis für interdisziplinäre Onkologie & Hämatologie
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연락하다:
- Patrick Marschner
- 전화번호: +49761386870
- 이메일: klifo@onkologie-freiburg.de
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Paderborn, 독일, 33098
- 모병
- St. Louise Frauen- und Kinderklinik
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연락하다:
- Michael P Lux
- 전화번호: +49 5251864121
- 이메일: M.Lux@vincenz.de
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Ravensburg, 독일, 88212
- 모병
- Gemeinschaftspraxis für Hämatologie und Onkologie
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연락하다:
- Thomas Decker
- 전화번호: +49 751 366197-0
- 이메일: thomas.decker@onkonet.eu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
확률 샘플
연구 인구
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).
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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ESR1 wildtype
Patients with a ESR1 wildtype tumor
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Treatment decision of investigator
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ESR1 mutated
Patients with a ESR1 mutated tumor
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According to the Summary of Product Characteristics (SmPC)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in EORTC global health scale
기간: From Time of enrollment until month 11
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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.
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From Time of enrollment until month 11
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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설문지를 사용하여 의사의 치료 결정 매개변수를 평가합니다.
기간: 기준선
|
치료 선택에 영향을 미치는 고유한 매개변수의 빈도 담당 의사가 작성한 설문지.
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기준선
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Time to deterioration in global health scale (EORTC QLQ-C30)
기간: From Time of enrollment until month 11
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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.
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From Time of enrollment until month 11
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Time to deterioration in functional scores (EORTC QLQ-C30)
기간: From Time of enrollment until month 11
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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.
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From Time of enrollment until month 11
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Time to deterioration in symptom scores (EORTC QLQ-C30)
기간: From Time of enrollment until month 11
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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.
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From Time of enrollment until month 11
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Change from baseline in functional and symptom scores
기간: From Time of enrolment until up to 11 months after enrolment.
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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.
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From Time of enrolment until up to 11 months after enrolment.
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Change from baseline in visual analogue scale (VAS)
기간: From Time of enrollment until month 11.
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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.
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From Time of enrollment until month 11.
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Change from baseline in index value
기간: From Time of enrollment until month 11.
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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.
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From Time of enrollment until month 11.
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Change from baseline in all scales of EQ-5D-5L
기간: From Time of enrollment until month 11.
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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.
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From Time of enrollment until month 11.
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Prevalence of ESR1 mutation
기간: Baseline
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Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.
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Baseline
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Drug safety: Frequency
기간: From time of treatment start until 30 days after end of elacestrant treatment
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Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)
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From time of treatment start until 30 days after end of elacestrant treatment
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Drug safety: Incidence of adverse events
기간: From time of treatment start until 30 days after end of elacestrant treatment
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Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)
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From time of treatment start until 30 days after end of elacestrant treatment
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Drug safety: Change from baseline in AST (Aspartate Aminotransferase)
기간: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in AST
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
기간: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in ALT
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Drug safety: Change from baseline in bilirubin
기간: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Change from baseline in bilirubin
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From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
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Patients and disease characteristics: Age
기간: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (</≥ 65))
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Baseline
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Patients and disease characteristics: Body mass index (BMI)
기간: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))
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Baseline
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Patients and disease characteristics: ECOG Performance status
기간: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status
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Baseline
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Patients and disease characteristics: CCI (Charlson score and contributing diseases)
기간: Baseline
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Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
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Baseline
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Patients and disease characteristics: Time since diagnosis
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
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Baseline
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Patients and disease characteristics: TNM staging
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
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Baseline
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Patients and disease characteristics: Metastatic sites
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
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Baseline
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Patients and disease characteristics: Tumor Grading
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion
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Baseline
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Patients and disease characteristics: HR and HER2 status
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion
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Baseline
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Patients and disease characteristics: Prior adjuvant chemotherapy
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
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Baseline
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Patients and disease characteristics: Prior adjuvant endocrine therapy
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy
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Baseline
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Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting
기간: Baseline
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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)
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Baseline
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Patients and disease characteristics: Disease site
기간: At time of enrollment
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Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion
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At time of enrollment
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Patients and disease characteristics: concomitant diseases
기간: Baseline
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Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
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Baseline
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Use of concomitant medication
기간: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess the use of concomitant medication during treatment with elacestrant.
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment
기간: max. 24 months; at patient patient-specific start of treatment
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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)
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max. 24 months; at patient patient-specific start of treatment
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Details on treatment with elacestrant: reason for end of treatment
기간: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess reason for end of treatment (treatment with elacestrant)
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: dose intensity
기간: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: frequency and type of dose modification
기간: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Details on treatment with elacestrant: reasons for dose modifications and interruptions
기간: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Assess reasons for dose modifications and interruptions (elacestrant treatment)
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max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
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Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
기간: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)
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max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
기간: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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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)
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max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 수석 연구원: Thomas Decker, Professor, Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- 수석 연구원: Michael Patrick Lux, Professor, St. Louise Frauen- und Kinderklinik Paderborn
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 19일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2028년 6월 1일
연구 등록 날짜
최초 제출
2025년 12월 2일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 24일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IOM-090506
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .