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Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)

2020年4月6日 更新者：Novartis Pharmaceuticals

A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

235

阶段

  • 第三阶段

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。

学习地点

  • 南非
      • Western Cape、南非、7925
        • Novartis Investigative Site
    • Western Cape
      • Cape Town、Western Cape、南非、7925
        • Novartis Investigative Site
      • George、Western Cape、南非、6530
        • Novartis Investigative Site
  • 印度
    • Gujarat
      • Karamsad、Gujarat、印度、388325
        • Novartis Investigative Site
    • Maharashtra
      • Nashik、Maharashtra、印度、422 004
        • Novartis Investigative Site
      • Pune、Maharashtra、印度、411013
        • Novartis Investigative Site
    • Orissa
      • Cuttack、Orissa、印度、753 007
        • Novartis Investigative Site
  • 印度尼西亚
      • Bandung、印度尼西亚、40161
        • Novartis Investigative Site
      • Jakarta、印度尼西亚、11420
        • Novartis Investigative Site
      • Jogyakarta、印度尼西亚、55284
        • Novartis Investigative Site
      • Semarang、印度尼西亚、50212
        • Novartis Investigative Site
  • 台湾
      • Changhua、台湾、50006
        • Novartis Investigative Site
      • Kaohsiung City、台湾、83301
        • Novartis Investigative Site
      • Kaoshiung、台湾、80756
        • Novartis Investigative Site
      • Taipei、台湾、10048
        • Novartis Investigative Site
      • Taipei、台湾、10449
        • Novartis Investigative Site
    • TWN
      • New Taipei City、TWN、台湾、23561
        • Novartis Investigative Site
  • 大韩民国
      • Busan、大韩民国、602739
        • Novartis Investigative Site
      • Jeollanam-do、大韩民国、519763
        • Novartis Investigative Site
      • Seoul、大韩民国、03080
        • Novartis Investigative Site
      • Seoul、大韩民国、06351
        • Novartis Investigative Site
      • Seoul、大韩民国、03722
        • Novartis Investigative Site
      • Seoul、大韩民国、02841
        • Novartis Investigative Site
      • Seoul、大韩民国、06273
        • Novartis Investigative Site
      • Seoul、大韩民国、01812
        • Novartis Investigative Site
      • Taegu、大韩民国、41944
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon、Gyeonggi-do、大韩民国、443380
        • Novartis Investigative Site
    • Korea
      • Gyeonggi do、Korea、大韩民国、10408
        • Novartis Investigative Site
      • Seoul、Korea、大韩民国、05505
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul、Seocho Gu、大韩民国、06591
        • Novartis Investigative Site
  • 摩洛哥
      • Casablanca、摩洛哥
        • Novartis Investigative Site
      • Rabat、摩洛哥、6527
        • Novartis Investigative Site
  • 泰国
      • Bangkok、泰国、10400
        • Novartis Investigative Site
      • Bangkok、泰国、10300
        • Novartis Investigative Site
      • Chiang Mai、泰国、50200
        • Novartis Investigative Site
  • 澳大利亚
    • Australian Capital Territory
      • Garran、Australian Capital Territory、澳大利亚、2605
        • Novartis Investigative Site
    • New South Wales
      • Caringbah、New South Wales、澳大利亚、2229
        • Novartis Investigative Site
      • Liverpool、New South Wales、澳大利亚、2170
        • Novartis Investigative Site
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • Novartis Investigative Site
      • Heidelberg、Victoria、澳大利亚、3084
        • Novartis Investigative Site
      • Ringwood East、Victoria、澳大利亚、3135
        • Novartis Investigative Site
      • St Albans、Victoria、澳大利亚、3021
        • Novartis Investigative Site
  • 火鸡
      • Ankara、火鸡、06100
        • Novartis Investigative Site
      • Ankara、火鸡、06500
        • Novartis Investigative Site
      • Ankara、火鸡、06460
        • Novartis Investigative Site
      • Gaziantep、火鸡、27310
        • Novartis Investigative Site
      • Izmir、火鸡、35040
        • Novartis Investigative Site
      • Kartal、火鸡、34890
        • Novartis Investigative Site
      • Pendik / Istanbul、火鸡、34899
        • Novartis Investigative Site
  • 突尼斯
      • Ariana、突尼斯、2080
        • Novartis Investigative Site
  • 约旦
      • Amman、约旦、11941
        • Novartis Investigative Site
  • 越南
      • Ho Chi Minh、越南、700000
        • Novartis Investigative Site
  • 马来西亚
    • MYS
      • Kuala Lumpur、MYS、马来西亚、56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu、Sabah、马来西亚、88586
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur、Wilayah Persekutuan、马来西亚、50586
        • Novartis Investigative Site

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
  • Disease refractory to non-steroidal aromatase inhibitors, defined as:
  • Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
  • Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
  • Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
  • Patients must have had:

  • At least one lesion that could have been accurately measured in at least one dimension

    • 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
  • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
  • Adequate bone marrow, coagulation, liver and renal function.
  • ECOG performance status ≤ 2.

Exclusion Criteria:

  • Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
  • Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
  • Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
  • Previous treatment with mTOR inhibitors.
  • Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
  • Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
  • Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
  • History of brain or other CNS metastases, including leptomeningeal metastasis.

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

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
药品：everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
其他名称：
  • RAD001
药品：exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

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
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
大体时间：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Response Rates (Best Overall and Overall)
大体时间：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Percentage of Participants Clinical Benefit Rate
大体时间：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Progression Free Survival (PFS)
大体时间：Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries

PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.

b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)
Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
大体时间：Baseline up to approximately 50 weeks
Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.
Baseline up to approximately 50 weeks

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

Novartis Pharmaceuticals

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)

2013年3月29日

初级完成 (实际的)

2019年1月29日

研究完成 (实际的)

2019年1月29日

研究注册日期

首次提交

2017年6月1日

首先提交符合 QC 标准的

2017年6月1日

首次发布 (实际的)

2017年6月5日

研究记录更新

最后更新发布 (实际的)

2020年4月7日

上次提交的符合 QC 标准的更新

2020年4月6日

最后验证

2020年4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

  • CRAD001JIC06

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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