Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)
2020年3月4日 更新者：BELEN RUIZ-ANTORAN
Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
研究概览
地位
完全的
条件
详细说明
This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.
The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.
研究类型
观察性的
注册 (实际的)
220
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
-
-
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Madrid、西班牙、28222
- Puerta de Hierro University Hospital
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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 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program.
The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.
描述
Inclusion Criteria:
- Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
- Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.
Exclusion Criteria:
- Given the characteristics of the study there are no exclusion criteria.
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 |
|---|
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Pertuzumab
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
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Trastuzumab emtansine
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program
|
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 |
|---|---|---|
|
Overall survival.
大体时间：Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
|
The time between the date of start of treatment and the date of death.
For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
|
Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival.
大体时间：Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
|
The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
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Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
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Best overall response rate
大体时间：Through study completion, an average of 4 year
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Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
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Through study completion, an average of 4 year
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Duration of response (DOR)
大体时间：Through study completion, an average of 4 year
|
The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first.
At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
|
Through study completion, an average of 4 year
|
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Time to treatment failure
大体时间：Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
|
|
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Time to Objective Response
大体时间：Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
|
The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
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Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
|
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Time to change treatment
大体时间：Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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|
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Time to next treatment
大体时间：Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
|
|
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All suspected Grade 3/4/5 adverse reactions
大体时间：Through study completion, an average of 4 year
|
Through study completion, an average of 4 year
|
|
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Adverse events of special interest to anti HER2 Mab (AESI)
大体时间：Through study completion, an average of 4 year
|
|
Through study completion, an average of 4 year
|
|
AEs of scientific interest
大体时间：Through study completion, an average of 4 year
|
|
Through study completion, an average of 4 year
|
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。
调查人员
- 首席研究员：Belén Ruiz-Antorán, PhD、Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
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)
2017年12月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2020年1月31日
研究注册日期
首次提交
2017年1月11日
首先提交符合 QC 标准的
2017年1月16日
首次发布 (估计)
2017年1月19日
研究记录更新
最后更新发布 (实际的)
2020年3月5日
上次提交的符合 QC 标准的更新
2020年3月4日
最后验证
2020年3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.