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.
調査の概要
研究の種類
観察的
入学 (推定)
500
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Laura Serrer
- 電話番号：+49761152420
- メール：eleni@iomedico.com
研究場所
-
-
-
Freiburg im Breisgau、ドイツ、79110
- 募集
- Praxis für interdisziplinäre Onkologie & Hämatologie
-
コンタクト：
- Patrick Marschner
- 電話番号：+49761386870
- メール：klifo@onkologie-freiburg.de
-
Paderborn、ドイツ、33098
- 募集
- St. Louise Frauen- und Kinderklinik
-
コンタクト：
- Michael P Lux
- 電話番号：+49 5251864121
- メール：M.Lux@vincenz.de
-
Ravensburg、ドイツ、88212
- 募集
- Gemeinschaftspraxis für Hämatologie und Onkologie
-
コンタクト：
- Thomas Decker
- 電話番号：+49 751 366197-0
- メール：thomas.decker@onkonet.eu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
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).
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
ESR1 wildtype
Patients with a ESR1 wildtype tumor
|
Treatment decision of investigator
|
|
ESR1 mutated
Patients with a ESR1 mutated tumor
|
According to the Summary of Product Characteristics (SmPC)
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in EORTC global health scale
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
アンケートを使用して医師の治療決定のパラメータを評価する
時間枠：ベースライン
|
治療法の選択に影響を与える個別のパラメーターの頻度。担当医師が記入したアンケート。
|
ベースライン
|
|
Time to deterioration in global health scale (EORTC QLQ-C30)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
|
Baseline
|
|
Patients and disease characteristics: TNM staging
時間枠：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
時間枠：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
|
Baseline
|
|
Patients and disease characteristics: Tumor Grading
時間枠：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
時間枠：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
時間枠：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
|
Baseline
|
|
Patients and disease characteristics: Prior adjuvant endocrine therapy
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
|
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
|
Baseline
|
|
Use of concomitant medication
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Thomas Decker, Professor、Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
- 主任研究者：Michael Patrick Lux, Professor、St. Louise Frauen- und Kinderklinik Paderborn
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月19日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年6月1日
試験登録日
最初に提出
2025年12月2日
QC基準を満たした最初の提出物
2026年4月29日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25日
QC基準を満たした最後の更新が送信されました
2026年6月24日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IOM-090506
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。