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EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC) (MBC)

2026年6月9日 更新者：Tel-Aviv Sourasky Medical Center

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.

This phase II, open-label, single-arm, study investigates the clinical benefit of everolimus combined with endocrine therapy (ET) in hormone receptor-positive (HR+), metastatic breast cancer (MBC) patients who progressed on prior PI3K inhibitor therapy (+ ET). 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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

19

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：Breast Cancer coordinator Breast Cancer coordinator
  • 电话号码：972-03-6974092
  • 邮箱：hananm@tlvmc.gov.il

学习地点

  • 以色列
      • Tel Aviv、以色列
        • 招聘中
        • Ichilov-Sourasky Medical Center
        • 接触：
          • Hanan Mansour Breast cancer study coordinator
          • 电话号码：97236974062
          • 邮箱：hananm@tlvmc.gov.il

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

HR+ MBC post CDK 4/6 inhibitors and anti PI3K inhibitor.

描述

Inclusion Criteria:

  • HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET

Exclusion Criteria:

  • Women who didn't receive anti-PI3K

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
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.
药品：Everolimus (Afinitor) tablets with endocrine therapy
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."
程序：Blood draw for biomarker and genetic analysis
"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."

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
ORR
大体时间：Response rate- From enrollment to the first scan at 8-12 weeks
Objective response rate -best response rate in the first scan 8-12 weeks from day1
Response rate- From enrollment to the first scan at 8-12 weeks

次要结果测量

结果测量
措施说明
大体时间
PFS
大体时间：From date of enrollment until the date of first documented progression, assessed up to 24 months.
Time from Day 1 to progression, an average of 16 weeks
From date of enrollment until the date of first documented progression, assessed up to 24 months.
CBR Clinical Benefit Rate
大体时间：Through the end of the study, assessed up to 24 months.
Proportion with CR/PR or stable disease ≥24 weeks
Through the end of the study, assessed up to 24 months.

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

Tel-Aviv Sourasky Medical Center

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)

2022年9月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2025年5月15日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TLV-0295-21

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made available outside the primary research group to protect participant privacy and maintain confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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