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Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.

研究概览

详细说明

Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.

Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.

Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.

Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.

研究类型

介入性

注册 (估计的)

649

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。

学习联系方式

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • 接触:

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • ECOG performance status score of 0 to 2.
  • Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
  • Clinical stage cT0-2N0M0.
  • Underwent breast-conserving surgery.
  • Negative surgical margins greater than 2 mm.

Exclusion Criteria:

  • Regional lymph node metastasis.
  • Distant metastasis.
  • Bilateral breast cancer.
  • Prior thoracic radiotherapy.
  • Life expectancy of less than 5 years.
  • Lactating or pregnant women.

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:治疗
  • 分配:非随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Arm 1: High-risk group

Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:

  • Age younger than 40 years.

    • Histology of invasive lobular carcinoma or micropapillary carcinoma.

      • Multifocal disease, defined as two or more breast tumor foci.

        • Tumor size greater than 3 cm.

          • Lymphovascular invasion.

            • Invasive carcinoma with an extensive intraductal component.

              • Estrogen receptor-negative disease.

Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:

  • Age younger than 40 years.

    • Histology of invasive lobular carcinoma or micropapillary carcinoma.

      • Multifocal breast tumor before treatment.

        • Lymphovascular invasion.

          • Pathologic stage ypT1-2N0.
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions
有源比较器:Arm 2: Low-risk group

Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria:

① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease.

② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease.

Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0.

Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions

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
Local recurrence rate
大体时间:Five years
Ipsilateral breast recurrence rate
Five years

次要结果测量

结果测量
措施说明
大体时间
Disease-free survival rate
大体时间:Five years
Disease-free survival rate
Five years
Radiation-related adverse events
大体时间:Five years
Adverse events
Five 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。

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6月15日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年6月14日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • NCC25/095-0095

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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