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International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)

2020年5月19日 更新者：AstraZeneca

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Background/Rationale: Within the setting of metastatic human epidermal growth factor receptor 2 negative (HER2-ve) breast cancer limited epidemiological data exist on the prevalence of pathogenic mutations of breast cancer susceptibility gene (BRCA) and other homologous recombination repair (HRR) genes. There are also limited data on the treatments and clinical outcomes of patients with such germline and somatic genetic profiles, particularly within this setting. This epidemiologic study will estimate the prevalence of germline breast susceptibility gene (gBRCA) mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy and, at that time, are considered to have exhausted hormone therapy options (if hormone receptor positive [HR+ve]), per investigator's opinion. Among those patients with a gBRCA gene mutation, treatment patterns and clinical outcomes will be described. This study may also explore the prevalence of somatic BRCA (sBRCA) mutations and other HRR gene mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy. The treatment patterns and clinical outcomes may be described among those patients with a sBRCA gene mutation and those with other HRR gene mutations.

研究类型

观察性的

注册 (实际的)

873

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

  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦
        • Research Site
      • Krasnodar、俄罗斯联邦
        • Research Site
      • Novosibirsk、俄罗斯联邦
        • Research Site
      • Omsk、俄罗斯联邦
        • Research Site
      • Pyatigorsk、俄罗斯联邦
        • Research Site
      • Ryazan、俄罗斯联邦
        • Research Site
      • Tomsk、俄罗斯联邦
        • Research Site
  • 保加利亚
      • Dobrich、保加利亚
        • Research Site
      • Ruse、保加利亚
        • Research Site
      • Sofia、保加利亚
        • Research Site
  • 加拿大
      • Quebec、加拿大、G1S 4L8
        • Research Site
    • Ontario
      • Kingston、Ontario、加拿大、K7L 5P9
        • Research Site
      • Kitchener、Ontario、加拿大、N2G 1G3
        • Research Site
    • Quebec
      • Chicoutimi、Quebec、加拿大、G7H 5H6
        • Research Site
  • 匈牙利
      • Budapest、匈牙利
        • Research Site
      • Szeged、匈牙利
        • Research Site
      • Szekszard、匈牙利
        • Research Site
      • Szolnok、匈牙利
        • Research Site
  • 台湾
      • Changhua、台湾
        • Research Site
      • Kaohsiung、台湾
        • Research Site
      • Taichung、台湾
        • Research Site
      • Tainan、台湾
        • Research Site
      • Taipei、台湾
        • Research Site
  • 大韩民国
      • Busan、大韩民国
        • Research Site
      • Seoul、大韩民国
        • Research Site
      • Ulsan、大韩民国
        • Research Site
    • Gyeonggi-do
      • Goyang-si、Gyeonggi-do、大韩民国
        • Research Site
      • Seongnam-si、Gyeonggi-do、大韩民国
        • Research Site
      • Seongnam-si,、Gyeonggi-do、大韩民国
        • Research Site
  • 德国
      • Tubingen、德国
        • Research Site
  • 意大利
      • Milano、意大利
        • Research Site
      • Pavia、意大利
        • Research Site
      • Reggio Emilia、意大利
        • Research Site
    • Modena
      • Carpi、Modena、意大利
        • Research Site
    • Varese
      • Castellanza、Varese、意大利
        • Research Site
  • 日本
    • Chiba-Ken
      • Kamogawa-shi、Chiba-Ken、日本
        • Research Site
    • Ehime-Ken
      • Matsuyama-shi、Ehime-Ken、日本
        • Research Site
    • Fukuoka-Ken
      • Fukuoka-shi、Fukuoka-Ken、日本
        • Research Site
    • Hokkaido
      • Sapporo-shi、Hokkaido、日本
        • Research Site
    • Miyagi-Ken
      • Sendai-shi、Miyagi-Ken、日本
        • Research Site
    • Osaka-Fu
      • Osaka-shi、Osaka-Fu、日本
        • Research Site
    • Tokyo-To
      • Chuo-ku、Tokyo-To、日本
        • Research Site
  • 波兰
      • Brzozow、波兰
        • Research Site
      • Opole、波兰
        • Research Site
      • Walbrzych、波兰
        • Research Site
      • Warszawa、波兰
        • Research Site
      • Wieliszew、波兰
        • Research Site
      • Wroclaw、波兰
        • Research Site
      • Zory、波兰
        • Research Site
  • 澳大利亚
    • Queensland
      • Redcliffe、Queensland、澳大利亚
        • Research Site
    • South Australia
      • Kurralta Park、South Australia、澳大利亚
        • Research Site
    • Victoria
      • Ballarat、Victoria、澳大利亚
        • Research Site
  • 火鸡
      • Adana、火鸡
        • Research Site
      • Ankara、火鸡
        • Research Site
      • Antalya、火鸡
        • Research Site
      • Diyarbakir、火鸡
        • Research Site
      • Istanbul、火鸡
        • Research Site
      • Izmir、火鸡
        • Research Site
      • Kocaeli、火鸡
        • Research Site
      • Sakarya、火鸡
        • Research Site
      • Samsun、火鸡
        • Research Site
      • Tekirdag、火鸡
        • Research Site
      • Trabzon、火鸡
        • Research Site
      • Van、火鸡
        • Research Site
  • 美国
    • California
      • Santa Barbara、California、美国、93105
        • Research Site
    • Colorado
      • Denver、Colorado、美国、80218
        • Research Site
    • Florida
      • Hialeah、Florida、美国、33012
        • Research Site
    • Texas
      • Dallas、Texas、美国、75246
        • Research Site
      • Denton、Texas、美国、76210
        • Research Site
      • Flower Mound、Texas、美国、75028
        • Research Site
      • Houston、Texas、美国、77024
        • Research Site
      • Houston、Texas、美国、77089
        • Research Site
      • Paris、Texas、美国、75460
        • Research Site
      • San Antonio、Texas、美国、78217
        • Research Site
      • The Woodlands、Texas、美国、77380
        • Research Site
    • Virginia
      • Newport News、Virginia、美国、23601
        • Research Site
    • Washington
      • Vancouver、Washington、美国、98684
        • Research Site
      • Wenatchee、Washington、美国、98801
        • Research Site
  • 英国
    • Cambridgeshire
      • Huntingdon、Cambridgeshire、英国
        • Research Site
      • Peterborough、Cambridgeshire、英国
        • Research Site
    • Cornwall
      • Truro、Cornwall、英国
        • Research Site
    • Derbyshire
      • Derby、Derbyshire、英国
        • Research Site
    • Devon
      • Exeter、Devon、英国
        • Research Site
    • East Sussex
      • Worthing、East Sussex、英国
        • Research Site
    • Greater London
      • London、Greater London、英国
        • Research Site
    • Lancashire
      • Blackpool、Lancashire、英国
        • Research Site
      • Lancaster、Lancashire、英国
        • Research Site
    • Staffordshire
      • Stoke on Trent、Staffordshire、英国
        • Research Site
    • Warwickshire
      • Warwick、Warwickshire、英国
        • Research Site
    • West Midlands
      • Wolverhampton、West Midlands、英国
        • Research Site
    • West Yorkshire
      • Huddersfield、West Yorkshire、英国
        • Research Site
  • 西班牙
      • Barcelona、西班牙
        • Research Site
      • Burgos、西班牙
        • Research Site
      • Girona、西班牙
        • Research Site
      • Huelva、西班牙
        • Research Site
    • Barcelona
      • Terrassa、Barcelona、西班牙
        • Research Site
    • La Coruña
      • A Coruna、La Coruña、西班牙
        • Research Site
    • Madrid
      • Alcorcon、Madrid、西班牙
        • Research Site
      • San Sebastian de los Reyes、Madrid、西班牙
        • Research 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

取样方法

非概率样本

研究人群

Centers for primary care of metastatic HER2-ve breast cancer patients

描述

Inclusion Criteria:

  1. Provision of signed, written and dated informed consent.
  2. Adult females (according to the age of majority/adulthood as defined by local regulations).
  3. Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease.
  4. Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal therapy) for metastatic breast cancer in the last 90 days and, at that time, are considered to have exhausted hormone therapy options (if HR+ve).

Exclusion Criteria:

  1. Previous enrolment in this study.
  2. Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site).
  3. Current participation in a clinical study with an investigational oncology product.
  4. Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy.
  5. Current commencement of PARPi 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

队列和干预

团体/队列
干预/治疗
Observation
Human epidermal growth factor receptor 2 negative metastic breast cancer patients who have started 1st line systemic cytotoxic chemotheraphy and are considered to have exhausted hormone therapy options (if HR+ve), per investigator's opinion.
遗传的：Germline BRCA Test (blood)
If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.)
遗传的：FoundationOne Dx Genomic Profile (archival Tumour Specimen)

Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows:

  • Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies.
  • Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile.
其他：Follow-up

Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months.

- Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study.

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
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
大体时间：At one time point at inclusion in the study up to 12 months after the beginning of the study.
The prevalence of gBRCA gene mutations will be evaluated by calculating the proportion of patients that test positive for a gBRCA gene mutation (BRCA1 mutated and/or BRCA2 mutated).
At one time point at inclusion in the study up to 12 months after the beginning of the study.

次要结果测量

结果测量
措施说明
大体时间
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
大体时间：2.5 years (30 months) since the beginning of the study.
Treatment patterns will be described by line of therapy. Treatment combinations, number of cycles per line, schedules, durations, and reason for discontinuation will be summarized descriptively.
2.5 years (30 months) since the beginning of the study.
Progression free survival by line of therapy
大体时间：2.5 years (30 months) since the beginning of the study.
Progression free survival (in months) for each line of treatment, defined as the time from the date of start of each line of treatment to the documented date of progression as determined by the investigator (radiologic or symptomatic), or death from any cause in the absence of progression.
2.5 years (30 months) since the beginning of the study.
Overall survival by line of therapy
大体时间：2.5 years (30 months) since the beginning of the study.
Overall survival (OS) defined as the time from the start date of first line chemotherapy in the metastatic setting until the date of death due to any cause, assessed up to 30 months. In addition, OS since diagnosis of metastatic breast cancer and OS since the start of each subsequent therapy will be estimated.
2.5 years (30 months) since the beginning of the study.

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

AstraZeneca

合作者

Quintiles; University of Tubingen - Germany

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。

一般刊物

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 (实际的)

2017年3月13日

初级完成 (实际的)

2019年5月20日

研究完成 (实际的)

2019年5月20日

研究注册日期

首次提交

2017年2月10日

首先提交符合 QC 标准的

2017年3月7日

首次发布 (实际的)

2017年3月13日

研究记录更新

最后更新发布 (实际的)

2020年5月20日

上次提交的符合 QC 标准的更新

2020年5月19日

最后验证

2020年5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

  • D0816R00012

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

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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