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An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

2013年12月5日 更新者：Boehringer Ingelheim

An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen

The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.

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)

50

阶段

  • 阶段2

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

  • 德国
      • Berlin、德国
        • 1200.10.49005 Boehringer Ingelheim Investigational Site
      • Düsseldorf、德国
        • 1200.10.49007 Boehringer Ingelheim Investigational Site
      • Erlangen、德国
        • 1200.10.49008 Boehringer Ingelheim Investigational Site
      • Essen、德国
        • 1200.10.49010 Boehringer Ingelheim Investigational Site
      • Kiel、德国
        • 1200.10.49003 Boehringer Ingelheim Investigational Site
      • Mainz、德国
        • 1200.10.49004 Boehringer Ingelheim Investigational Site
      • München、德国
        • 1200.10.49001 Boehringer Ingelheim Investigational Site
      • Wiesbaden、德国
        • 1200.10.49006 Boehringer Ingelheim Investigational Site
  • 比利时
      • Brussel、比利时
        • 1200.10.3208 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 1200.10.3201 Boehringer Ingelheim Investigational Site
      • Charleroi、比利时
        • 1200.10.3203 Boehringer Ingelheim Investigational Site
      • Gent、比利时
        • 1200.10.3205 Boehringer Ingelheim Investigational Site
      • Leuven、比利时
        • 1200.10.3204 Boehringer Ingelheim Investigational Site
      • Wilrijk、比利时
        • 1200.10.3206 Boehringer Ingelheim Investigational 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:

Inclusion Criteria:

  • Female patients age 18 years or older
  • Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
  • HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
  • At least one measurable tumour lesion (RECIST);
  • Availability of tumour samples
  • Written informed consent that is consistent with ICH-GCP guidelines and local law
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.

Exclusion criteria:

Exclusion Criteria:

  • Active infectious disease
  • Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
  • Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
  • Active/symptomatic brain metastases
  • Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
  • ANC less than 1500/mm3 platelet count less than 100 000/mm3
  • Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
  • AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
  • Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breast-feeding
  • Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
  • Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • Other malignancy within the past 5 years

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：诊断
  • 分配：非随机化
  • 介入模型：并行分配
  • 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：BIBW 2992
high dose once daily
药品：BIBW 2992
high dose once daily

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
Objective Response (OR)
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Clinical Benefit (CB)
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

次要结果测量

结果测量
措施说明
大体时间
Clinical Benefit (CB)
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to OR
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Progression-free Survival (PFS)
大体时间：Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
大体时间：From randomisation to end of follow-up.
OS is defined as time from randomisation to death.
From randomisation to end of follow-up.
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
大体时间：Baseline and last assessment
LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
Baseline and last assessment
Best Change From Baseline in ECOG Performance Status
大体时间：baseline till end of treatment
Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).
baseline till end of treatment
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
大体时间：day 29
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
day 29

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

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2006年11月1日

初级完成 (实际的)

2009年5月1日

研究注册日期

首次提交

2007年1月22日

首先提交符合 QC 标准的

2007年1月22日

首次发布 (估计)

2007年1月23日

研究记录更新

最后更新发布 (估计)

2013年12月31日

上次提交的符合 QC 标准的更新

2013年12月5日

最后验证

2013年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1200.10
  • 2006-002018-36 (EudraCT编号：EudraCT)

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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条件

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