Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
2016年6月17日 更新者：Boehringer Ingelheim
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer.
The study will include patients who have and have not failed prior trastuzumab treatment.
研究概览
研究类型
介入性
注册 (实际的)
26
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
-
-
-
Seoul、大韩民国
- 1200.89.82001 Boehringer Ingelheim Investigational Site
-
Seoul、大韩民国
- 1200.89.82002 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bangkok、泰国
- 1200.89.66002 Boehringer Ingelheim Investigational Site
-
Bangkok、泰国
- 1200.89.66004 Boehringer Ingelheim Investigational Site
-
Chiangmai、泰国
- 1200.89.66003 Boehringer Ingelheim Investigational Site
-
Hat-Yai, Songkhla、泰国
- 1200.89.66001 Boehringer Ingelheim Investigational Site
-
-
-
-
Victoria
-
East Bentleigh、Victoria、澳大利亚
- 1200.89.61002 Boehringer Ingelheim Investigational Site
-
-
Western Australia
-
Perth、Western Australia、澳大利亚
- 1200.89.61003 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Ariana、突尼斯
- 1200.89.21601 Boehringer Ingelheim Investigational Site
-
Sousse、突尼斯
- 1200.89.21602 Boehringer Ingelheim Investigational Site
-
-
-
-
California
-
Los Angeles、California、美国
- 1200.89.10001 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Durham、North Carolina、美国
- 1200.89.10005 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bournemouth、英国
- 1200.89.44002 Boehringer Ingelheim Investigational Site
-
London、英国
- 1200.89.44001 Boehringer Ingelheim Investigational Site
-
London、英国
- 1200.89.44003 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Hong Kong、香港
- 1200.89.85201 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:
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- Must have biopsiable disease
Exclusion criteria:
- Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- Must not have received prior vinorelbine treatment
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：Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
|
Patient to receive afatinib monotherapy until progression of their disease
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
|
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 |
|---|---|---|
|
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
大体时间：This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
|
This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
大体时间：This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
|
This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
大体时间：This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
大体时间：This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
|
|
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
大体时间：This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
大体时间：This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
|
Part A: Duration of Unconfirmed Objective Response.
大体时间：From first drug administration until end of Part A, up to 929 days.
|
Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR).
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
|
From first drug administration until end of Part A, up to 929 days.
|
|
Part B: Duration of Unconfirmed Objective Response.
大体时间：From first drug administration until end of Part B, up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
|
From first drug administration until end of Part B, up to 929 days.
|
|
Part A: Progression Free Survival.
大体时间：From first drug administration until end of Part A, up to 713 days.
|
PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study A.
|
From first drug administration until end of Part A, up to 713 days.
|
|
Part B: Progression Free Survival.
大体时间：From first drug administration until end of Part B, up to 230 days.
|
PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study B.
|
From first drug administration until end of Part B, up to 230 days.
|
|
Progression Free Survival Over the Whole Sudy.
大体时间：From first drug administration until end of study, up to 700 days.
|
PD was evaluated according to the RECIST version 1.1.
Number of days from the start of monotherapy to the date of second PD.
|
From first drug administration until end of study, up to 700 days.
|
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。
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
2011年8月1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2014年11月1日
研究注册日期
首次提交
2011年3月28日
首先提交符合 QC 标准的
2011年3月28日
首次发布 (估计)
2011年3月29日
研究记录更新
最后更新发布 (估计)
2016年7月19日
上次提交的符合 QC 标准的更新
2016年6月17日
最后验证
2016年6月1日
更多信息
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.