EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC) (MBC)
EVERST- Everolimus After Alpelisib in Women With HR+ MBC- This Phase II, Open-label, Single-arm, Study Investigates the Clinical Benefit of Everolimus Combined With Endocrine Therapy. in Hormone Receptor-positive (HR+), Metastatic Breast Cancer Patients Who Progressed on Prior PI3K Inhibitor Therapy With Endocrine Therapy. The Trial Aims to Determine if Sequential Inhibition of the PI3K/AKT/mTORC1 Pathway Retains Efficacy Post-PI3K Inhibitor Resistance, Hypothesizing That Everolimus Will Demonstrate a Response Rate Exceeding the Historical 9.5% Observed in the BOLERO2 Trial.
調査の概要
状態
条件
詳細な説明
Detailed Description The study employs a two-stage design to evaluate the primary endpoint of clinical response rate (complete/partial response per RECIST v1.1). Stage 1 will enroll 19 patients with measurable disease; if no responses are observed, the trial terminates. If ≥1 response occurs, 24 additional patients will be enrolled (total N=43), with success defined as ≥2 responses. Secondary endpoints include progression-free survival (PFS), clinical benefit rate (CBR), and biomarker analysis via longitudinal ctDNA profiling to identify genomic drivers of resistance/sensitivity. Eligible participants receive everolimus (10 mg/day) + ET until progression, unacceptable toxicity, or withdrawal. Tumor assessments occur every 8 weeks, with toxicity monitoring.
Study Design
Intervention Model: Single-group assignment
Primary Purpose: Treatment
Phase: II
Allocation: Non-randomized
Masking: None (open-label)
Outcome Measures
Primary: Objective response rate (ORR).
Secondary:
PFS (time from treatment initiation to progression/death).
CBR (proportion with CR/PR or stable disease ≥24 weeks).
Biomarker correlation (e.g., ESR1 mutations, PTEN alterations) via ctDNA analysis.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Breast Cancer coordinator Breast Cancer coordinator
- 電話番号：972-03-6974092
- メール：hananm@tlvmc.gov.il
研究場所
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Tel Aviv、イスラエル
- 募集
- Ichilov-Sourasky Medical Center
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コンタクト：
- Hanan Mansour Breast cancer study coordinator
- 電話番号：97236974062
- メール：hananm@tlvmc.gov.il
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参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET
Exclusion Criteria:
- Women who didn't receive anti-PI3K
研究計画
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 |
|---|---|
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HR+MBC post Alpelisib
Patients with HR+MBC post Alpelisib treatment who are scheduled to receive Everolimus with endocrine therapy, an additional blood sample is collected for biomarker evaluation.
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Patients receive standard of care treatment as prescribed by their treating physician.
This study only observes the outcomes and does not alter the treatment regimen, dosing, or schedule."
"A supplementary blood sample is collected from participants to analyze genetic and molecular biomarkers, aiming to identify potential correlations between these markers and clinical response to the standard treatment."
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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 |
|---|---|---|
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ORR
時間枠：Response rate- From enrollment to the first scan at 8-12 weeks
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Objective response rate -best response rate in the first scan 8-12 weeks from day1
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Response rate- From enrollment to the first scan at 8-12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PFS
時間枠：From date of enrollment until the date of first documented progression, assessed up to 24 months.
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Time from Day 1 to progression, an average of 16 weeks
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From date of enrollment until the date of first documented progression, assessed up to 24 months.
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CBR Clinical Benefit Rate
時間枠：Through the end of the study, assessed up to 24 months.
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Proportion with CR/PR or stable disease ≥24 weeks
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Through the end of the study, assessed up to 24 months.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- TLV-0295-21
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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