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对患有 ER+ 乳腺癌且无需手术的老年女性进行纵向 ctDNA 监测

2026年11月2日 更新者:Emilia J Diego, MD、University of Pittsburgh

对放弃前期手术转而接受主要内分泌治疗的 ER+ 乳腺癌老年女性进行纵向 ctDNA 监测

This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.

研究概览

地位

主动,不招人

条件

详细说明

Age is one of the most important risk factors for the development of breast cancer. Nearly a third of all breast cancer cases occur in older women (aged ≥ 70 years), with most cases being estrogen receptor-positive (ER+). Such tumours are unlikely to be the ultimate cause of death for older women, particularly when considering other comorbidities. Our group has recently shown that risk of breast cancer-related mortality is only around 3% for older women who forego upfront surgery and instead treated with primary endocrine monotherapy. However, with omission of surgery, surveillance for tumor growth or treatment failure is important but requires patients (and their caregivers) to have regular imaging and to see their oncology team every 3 months, which can be quite burdensome. Thus, this study employs a ctDNA surveillance scheme to monitor for potential tumor growth. Partnering with Natera, this study uses a bespoke, tumor-specific ctDNA assay (Signatera) to monitor for changes in ctDNA dynamics while the patient is on endocrine therapy.

This study is for patients who choose not to undergo primary surgical intervention and are managed medically on primary endocrine therapy (any endocrine therapy permitted). Patients will undergo Signatera testing at the time of regularly scheduled clinic follow-up visits and/or at the time of surveillance imaging, which will occur every 3-6 months. Patients will also be asked to complete regular surveys while participating in the study.

研究类型

观察性的

注册 (实际的)

49

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • UPMC Magee Womens Hospital - Surgical Oncology

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

70年 及以上 (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

Women 70 years of age or older with ER+/HER2-, non-metastatic breast cancer who forego upfront surgery in favor of primary endocrine therapy.

描述

Inclusion Criteria:

  • early-stage (stages I-III) breast cancer
  • estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative
  • able to provide blood samples
  • decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy
  • non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease)
  • patients may be taking any endocrine therapy
  • patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician
  • any ECOG Performance Status allowed
  • if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing
  • patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing

Exclusion Criteria:

  • under 70 years of age
  • breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+)
  • unable to provide blood samples or insufficient tumor tissue for Signatera testing

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:COHORT
  • 时间观点:PROSPECTIVE

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
Proportion of ctDNA positivity
大体时间:Up to 5 years

Proportion of patients with ER+/HER2- breast cancer who omit upfront surgery in favor of primary endocrine therapy who have any ctDNA positivity using Signatera assay.

Up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival (PFS)
大体时间:Up to 5 years

The length of time after treatment initiation that patient is alive and without any evidence of tumor progression as defined by RECIST1.1 criteria. Per RECISIT v1.1: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Up to 5 years
Breast cancer-specific survival (BCSS)
大体时间:Up to 5 years

BCSS is defined as the length of time from the date of diagnosis through the end of follow up that patients are free from breast cancer-related mortality.

Up to 5 years
Overall survival (OS)
大体时间:Up to 5 years

The length of time from the date of diagnosis through the end of follow up that patients are still alive.

Up to 5 years
Longitudinal quality of life assessment using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version (NCCN NFBSI-16)
大体时间:Up to 5 years

This assessment is a 16 item questionnaire using Likert scale (0-4) measured with each ctDNA blood draw. Score ranges from 0-64 with higher scores indicative of higher quality of life / asymptomatic from cancer-related therapy.

Up to 5 years

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。

合作者

调查人员

  • 首席研究员:Priscilla McAuliffe, MD, PhD、UPMC Magee Women's Hospital, UPMC Hillman 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 (实际的)

2022年4月19日

初级完成 (实际的)

2024年10月16日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2023年6月13日

首先提交符合 QC 标准的

2023年6月13日

首次发布 (实际的)

2023年6月22日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • HCC 22-088
  • STUDY21100091 (其他标识符:University of Pittsburgh)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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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