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Lapatinib Resistance in Patients With Breast Cancer

2015年10月1日更新者：Case Comprehensive Cancer Center

Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.

PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

研究概览

地位

撤销

条件

乳腺癌

干预/治疗

详细说明

OBJECTIVES:

To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
To investigate ErbB2 copy number changes and expression levels.
To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.

OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.

NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

研究类型

观察性的

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

美国
- Ohio
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  - Cleveland、Ohio、美国、44106-5065
    - Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  - Cleveland、Ohio、美国、44024
    - Geauga Regional Hospital
  - Cleveland、Ohio、美国、44060
    - Lake/University Ireland Cancer Center
  - Cleveland、Ohio、美国、44121
    - University Suburban Health Center
  - Cleveland、Ohio、美国、44122
    - UHHS Chagrin Highlands Medical Center
  - Cleveland、Ohio、美国、44130
    - Southwest General Health Center
  - Cleveland、Ohio、美国、44145
    - UHHS Westlake Medical Center
  - Cleveland、Ohio、美国、44708
    - Mercy Cancer Center at Mercy Medical Center

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

孩子
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

概率样本

研究人群

Primary care clinic

描述

DISEASE CHARACTERISTICS:

Pathologically confirmed invasive breast cancer
- ErbB2-positive disease
Has received or is currently receiving lapatinib ditosylate
- Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
Must have tumor tissue samples available for research studies
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Not pregnant*
Coagulation profile normal*
Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy

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

研究衡量的是什么？

主要结果指标

结果测量
Secondary ErbB2 mutations
ErbB2 copy number changes and expression levels
Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance

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

Case Comprehensive Cancer Center

合作者

National Cancer Institute (NCI)

调查人员

首席研究员：Balazs Halmos, MD、Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

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

2008年7月1日

研究注册日期

首次提交

2009年5月9日

首先提交符合 QC 标准的