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FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

2018年4月13日 更新者：Hannah Linden、University of Washington

Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET

This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

PRIMARY OBJECTIVES:

I. Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.

SECONDARY OBJECTIVES:

I. Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.

II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.

OUTLINE:

Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.

研究类型

介入性

注册 (实际的)

28

阶段

  • 不适用

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
    • Washington
      • Seattle、Washington、美国、98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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

全部

描述

Inclusion Criteria:

  • A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
  • Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
  • Have tissue block available from core biopsy for correlative biomarkers and genomic assay

  • Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as

    • A prior documented bilateral oophorectomy, or
    • A history of at least 12 months without spontaneous menstrual bleeding, or
    • Age 60 or older with a prior hysterectomy without oophorectomy, or
    • Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab
  • Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
  • Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed
  • Be a candidate for [18F]FLT PET imaging
  • Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
  • Be willing and able to comply with scheduled visits and other trial procedures

Exclusion Criteria:

  • Current use of aromatase inhibitor as prevention or treatment for breast cancer
  • Life expectancy of less than two months
  • HER2/neu positive by IHC and/or another FDA approved HER2 testing method
  • Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
  • Weight exceeding capacity of imaging table

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：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：Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
其他：实验室生物标志物分析
相关研究
药品：氟胸苷 F-18
进行FLT PET
其他名称：
  • 18F-FLT
  • 3'-脱氧-3'-[18F]氟胸苷
程序：正电子发射断层扫描
进行FLT PET
其他名称：
  • 医学成像、正电子发射断层扫描
  • 宠物
  • 宠物扫描
  • 正电子发射断层扫描
药品：Run-in (short pre-surgery course) of endocrine-targeted therapy
Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.

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
Percent Change in Net Influx Constant (Ki) by FLT PET
大体时间：Baseline to up to 6 weeks

Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.

Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Baseline to up to 6 weeks
Percent Change in SUV by FLT PET
大体时间：Baseline to up to 6 weeks
Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
Baseline to up to 6 weeks
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
大体时间：1 to 6 weeks post-therapy start
Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.
1 to 6 weeks post-therapy start
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
大体时间：Baseline to up to 6 weeks

Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.

The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient.

Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Baseline to up to 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
大体时间：Baseline to up to 6 weeks
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Baseline to up to 6 weeks
Baseline Ki (Flux Constant) Values by FLT PET
大体时间：Baseline
Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
Baseline
Baseline FLT Transport (K1) Values by FLT PET
大体时间：Baseline
K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Baseline
Baseline Standardized Uptake Values (SUV) by FLT PET
大体时间：Baseline
FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Baseline
Post-therapy Ki (Flux Constant) Values by FLT PET
大体时间：1 to 6 weeks post-therapy start
Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
1 to 6 weeks post-therapy start
Post-treatment FLT Transport (K1) Values by FLT PET
大体时间：1 to 6 weeks post-therapy start
K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
1 to 6 weeks post-therapy start
Post-treatment Standardized Uptake Values (SUV) by FLT PET
大体时间：1 to 6 weeks post-therapy start
FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
1 to 6 weeks post-therapy start

其他结果措施

结果测量
措施说明
大体时间
Post-treatment Gene Expression Levels
大体时间：1 to 6 weeks post-therapy start
Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
1 to 6 weeks post-therapy start
Pre-treatment Gene Expression Levels
大体时间：Baseline
Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
Baseline

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

University of Washington

合作者

National Cancer Institute (NCI)

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9月1日

初级完成 (实际的)

2015年7月20日

研究完成 (实际的)

2015年7月20日

研究注册日期

首次提交

2013年8月20日

首先提交符合 QC 标准的

2013年8月20日

首次发布 (估计)

2013年8月23日

研究记录更新

最后更新发布 (实际的)

2018年5月15日

上次提交的符合 QC 标准的更新

2018年4月13日

最后验证

2018年4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

  • 7536 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (美国 NIH 拨款/合同)
  • NCI-2013-01380 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • RC1CA146456 (美国 NIH 拨款/合同)

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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