Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (ELENI)
2026年6月24日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Laura Serrer
- 电话号码：+49761152420
- 邮箱：eleni@iomedico.com
学习地点
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-
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Freiburg im Breisgau、德国、79110
- 招聘中
- Praxis für interdisziplinäre Onkologie & Hämatologie
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接触：
- Patrick Marschner
- 电话号码：+49761386870
- 邮箱：klifo@onkologie-freiburg.de
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Paderborn、德国、33098
- 招聘中
- St. Louise Frauen- und Kinderklinik
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接触：
- Michael P Lux
- 电话号码：+49 5251864121
- 邮箱：M.Lux@vincenz.de
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Ravensburg、德国、88212
- 招聘中
- Gemeinschaftspraxis für Hämatologie und Onkologie
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接触：
- Thomas Decker
- 电话号码：+49 751 366197-0
- 邮箱：thomas.decker@onkonet.eu
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
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).
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in EORTC global health scale
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
使用问卷评估医生治疗决策的参数
大体时间：基线
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影响治疗选择的不同参数的频率；调查问卷由治疗医生完成。
|
基线
|
|
Time to deterioration in global health scale (EORTC QLQ-C30)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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.
|
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Change from baseline in all scales of EQ-5D-5L
大体时间：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.
|
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Prevalence of ESR1 mutation
大体时间：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
大体时间：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
|
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Drug safety: Incidence of adverse events
大体时间：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)
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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)
大体时间：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)
|
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Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
大体时间：From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
|
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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：Baseline
|
Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
|
Baseline
|
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Patients and disease characteristics: Time since diagnosis
大体时间：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
|
Baseline
|
|
Patients and disease characteristics: TNM staging
大体时间：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
|
Baseline
|
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Patients and disease characteristics: Metastatic sites
大体时间：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
|
Baseline
|
|
Patients and disease characteristics: Tumor Grading
大体时间：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
大体时间：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
大体时间：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
|
Baseline
|
|
Patients and disease characteristics: Prior adjuvant endocrine therapy
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
|
Baseline
|
|
Use of concomitant medication
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
调查人员
- 首席研究员：Thomas Decker, Professor、Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- 首席研究员：Michael Patrick Lux, Professor、St. Louise Frauen- und Kinderklinik Paderborn
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月19日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2025年12月2日
首先提交符合 QC 标准的
2026年4月29日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.