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Blood Biomarkers for Breast Cancer Treatment Response (TrackER)

2026年9月30日更新者：Marija Balic, MD PhD、University of Pittsburgh

Prospective Plasma Biomarker Study to Predict 2nd Line Endocrine Therapy Response in ER+ Metastatic Breast Cancer (TrackER)

This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work. It follows patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment.

Researchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time. By comparing blood test results with patient outcomes, the study aims to identify biomarkers that can predict which patients are most likely to benefit from treatment.

研究概览

地位

尚未招聘

条件

详细说明

This prospective observational study will enroll up to 200 patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment. The goal is to evaluate whether a blood-based biomarker, called the PERDI score, can predict how well patients respond to a second line hormone therapy.

Participants will provide a blood sample before starting treatment, with optional additional samples collected during treatment or at disease progression. Researchers will compare the blood test results with clinical outcomes, including how long the cancer remains under control, to determine whether the PERDI score can help identify patients who are most likely to benefit from treatment.

The study will be conducted across multiple sites within a single institution and will run for approximately 18 months, including a 12-month enrollment period and 6 months of follow-up. Findings from this study may help support more personalized treatment decisions and improve outcomes for patients with advanced breast cancer.

研究类型

观察性的

注册 (估计的)

200

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。

学习联系方式

姓名：Setareh Sharzehi, MD, PhD, MS
电话号码：(313) 452-3013
邮箱：sharzehis@upmc.edu

研究联系人备份

姓名：Marjia Balic, MD, PhD
邮箱：balicm@upmc.edu

学习地点

美国
- Pennsylvania
  - Pittsburgh、Pennsylvania、美国、15213
    - UPMC/Magee Hospital
    - 接触：
      
      Setareh Sharzehi Sharzehi, MD, PhD
      
      电话号码：(313) 452-3013
      
      邮箱：sharzehis@upmc.edu
    - 接触：
      
      Marjia Balic, MD,PHD
      
      邮箱：balicm@upmc.edu
    - 首席研究员：
      
      Marjia Balic, MD,PhD
    - 副研究员：
      
      Julia Foldi, MD, PhD
    - 副研究员：
      
      Adam Brufsky, MD
    - 副研究员：
      
      Charles Geyer, MD
    - 副研究员：
      
      Vikram Gorantla, MD
    - 副研究员：
      
      Monica Molhatra, MD
    - 副研究员：
      
      Priya Rastogi, MD

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

取样方法

非概率样本

研究人群

All patients with metastatic breast cancer refer to UPMC all sites

描述

Inclusion Criteria:

Patients must be ≥18 years of age
Cytologically or histologically confirmed invasive breast cancer that is:
1. Clinical stage IV
2. HR positive
3. Progressing on first line treatment
ECOG 0-2
Locally assessed ER+.
Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
No prior chemotherapy
Must have the ability to understand and the willingness to sign a written informed consent document.
Must be willing to provide serial blood samples for the study.

Exclusion Criteria:

1. Medical condition or social situation that may preclude adherence to the protocol.

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

观测模型：CASE_ONLY
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
breast cancer stage IV patients ER+ breast cancer stage IV patients after progression on first line treatment and will continue treatment with second line endocrine therapy

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
To Assess the performance of the baseline PERDI score 大体时间：From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year	Assessment of the performance of the baseline PERDI score, derived from plasma patients collected prior to the start of their second-line endocrine therapy (2L ET) using an epigenomics-based cell-free DNA (cfDNA) profiling assay, in predicting Progression-free survival (PFS).	From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year

次要结果测量

结果测量	措施说明	大体时间
Assessment of the baseline modified PERDI score 大体时间：6 months or 1 year after start 2L therapy	Preform a prospective cross-study meta-analysis of both PERDI and modifies PERDI. Progression-free survival (PFS) will be compared between modified PERDI-positive and negative derived from plasma collected at the start of second line therapy using epigenomics- based cfDNA profiling assay.	6 months or 1 year after start 2L therapy

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 Pittsburgh

合作者

Precede Biosciences

调查人员

首席研究员：Marjia Balic, MD, PhD、University of Pittsburgh

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

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 (估计的)

2026年11月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年9月16日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)