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Internal Mammary Node Irradiation After Neoadjuvant Systemic Therapy for Breast Cancer (IMN-Neo)

2026年11月3日 更新者：Mahidol University

Internal Mammary Node Irradiation Versus Omission of Internal Mammary Node Irradiation in Breast Cancer Treated With Neoadjuvant Systemic Therapy: A Phase III Multicenter Randomized Trial

This multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy.

Eligible participants will be randomly assigned in a 1:1 ratio to receive locoregional radiotherapy either with or without irradiation of the internal mammary lymph nodes. The primary outcome is disease-free survival. Secondary outcomes include overall survival, breast cancer mortality, locoregional recurrence-free survival, distant metastasis-free survival, and treatment-related toxicity, particularly cardiac and pulmonary toxicity.

A total of 1,760 participants are planned to be enrolled across multiple centers in Thailand.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Regional nodal irradiation is an established component of adjuvant radiotherapy for selected patients with node-positive breast cancer. However, the additional benefit of internal mammary node irradiation (IMNI) remains uncertain, particularly in patients receiving contemporary neoadjuvant systemic therapy. Although previous randomized trials have demonstrated potential oncologic benefits of regional nodal irradiation incorporating IMNI, most were conducted in patients undergoing upfront surgery, before the widespread use of modern systemic treatments. Consequently, the benefit-risk balance of IMNI in patients with residual nodal disease after neoadjuvant systemic therapy remains unclear.

IMN-Neo is a phase III, multicenter, randomized, open-label superiority trial designed to evaluate whether the addition of IMNI to standard locoregional radiotherapy improves oncologic outcomes in patients with residual pathologically positive axillary lymph nodes following neoadjuvant systemic therapy.

Participants will be randomized in a 1:1 ratio using computer-generated mixed block randomization, stratified by pathological nodal stage, method of axillary evaluation, primary tumor location, and breast cancer molecular subtype. Randomization will be performed at the time of radiotherapy simulation.

Both treatment groups will receive radiotherapy to the breast or chest wall and regional lymph nodes according to protocol-defined target delineation and dose constraints. The experimental group will additionally receive irradiation of the internal mammary lymph nodes, encompassing the first through third intercostal spaces, whereas the control group will undergo intentional omission of IMNI. Three-dimensional conformal radiotherapy or more advanced techniques will be used, with deep inspiration breath-hold permitted to minimize radiation exposure to surrounding normal tissues.

Participants will undergo scheduled clinical follow-up to assess disease recurrence, survival, and treatment-related adverse effects. Particular attention will be given to cardiac and pulmonary toxicity because of the potential increase in radiation exposure associated with IMNI.

An independent Data and Safety Monitoring Board will oversee participant safety and trial conduct. A prespecified interim efficacy analysis will be performed after approximately 50% of the required primary endpoint events have occurred, with additional monitoring for unexpected oncologic harm and serious treatment-related toxicity.

The trial aims to provide prospective evidence to guide individualized decision-making regarding IMNI in patients with residual nodal disease following contemporary neoadjuvant systemic therapy.

研究类型

介入性

注册 (估计的)

1760

阶段

  • 第三阶段

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

  • 泰国
      • Bangkok、泰国
        • Chulabhorn Hospital
        • 接触：
        • 副研究员：
          • Areeya Tinsurawattana, MD
      • Chon Buri、泰国
        • Chonburi Cancer Hospital
        • 接触：
      • Chon Buri、泰国
        • Vibharam Amata Nakorn Cancer Hospital
        • 接触：
      • Lopburi、泰国
        • Lop Buri Cancer Hospital
        • 接触：
      • Nakhon Pathom、泰国
        • Synphaet Hospital Nakhon Pathom
        • 接触：
      • Nakhon Si Thammarat、泰国
        • Maharaj Nakhon Si Thammarat Hospital
        • 接触：
      • Ratchaburi、泰国
        • Ratchaburi Hospital
        • 接触：
      • Samut Sakhon、泰国
        • Metropolitan Hospital Tha Chalom, Samut Sakhon Hospital
        • 接触：
    • Bangkok Noi
      • Bangkok、Bangkok Noi、泰国、10700
        • Siriraj Hospital
        • 接触：
        • 首席研究员：
          • Tanun Jitwatcharakomol, MD
        • 副研究员：
          • Pittaya Dankulchai, MD
        • 副研究员：
          • Janjira Petsuksiri, MD
        • 副研究员：
          • Chinnavuth Vatanashevanopakorn, MD
        • 副研究员：
          • Pongpop Tuntapakul, MD
        • 副研究员：
          • Wiwatchai Sittiwong, MD
        • 副研究员：
          • Ratchapas Romrattaphan, MD
        • 副研究员：
          • Krittee Chesdachai, 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

女性

描述

Inclusion Criteria:

  • Histologically confirmed breast cancer with pathologically proven lymph node positivity after neoadjuvant systemic therapy.
  • Received neoadjuvant chemotherapy and/or targeted therapy and/or immunotherapy before surgery.
  • Underwent either breast-conserving surgery or mastectomy with lymph node evaluation and is planned to receive adjuvant locoregional radiotherapy.
  • Planned treatment with three-dimensional conformal radiotherapy (3D-CRT) or a more advanced radiotherapy technique.
  • Female ≥ 18 years

Exclusion Criteria:

  • Clinical or radiologic evidence of internal mammary lymph node involvement of any size.
  • Inflammatory breast cancer.
  • Bilateral breast cancer.
  • Multiple primary malignancies, except basal cell carcinoma and premalignant gynecologic lesions including CIN, HSIL, LSIL, VIN, and VAIN.
  • Prior chest irradiation.
  • Disease progression before radiotherapy.
  • Metastatic disease (M1) according to the AJCC 8th edition.

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：随机化
  • 介入模型：并行分配
  • 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：IMNI Group

Participants will receive adjuvant locoregional radiotherapy including irradiation of the internal mammary lymph nodes.
辐射：Locoregional Radiotherapy With Internal Mammary Node Irradiation

Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, including the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.

其他名称：
  • IMNI Group
有源比较器：Non-IMNI Group

Participants will receive adjuvant radiotherapy to the breast or chest wall and regional lymph nodes without irradiation of the internal mammary lymph nodes.
辐射：Locoregional Radiotherapy Without Internal Mammary Node Irradiation

Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, with intentional omission of the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.

其他名称：
  • Non-IMNI Group

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
Disease-Free Survival (DFS)
大体时间：From randomization through 5 years

Disease-free survival is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
From randomization through 5 years

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to 5 years after randomization

Overall survival is defined as the time from randomization to death from any cause.
Up to 5 years after randomization
Breast Cancer Mortality
大体时间：Up to 5 years after randomization

Breast cancer mortality is defined as the time from randomization to death attributable to breast cancer.
Up to 5 years after randomization
Locoregional Recurrence-Free Survival (LRFS)
大体时间：Up to 5 years after randomization

Locoregional recurrence-free survival is defined as the time from randomization to the occurrence of locoregional recurrence.
Up to 5 years after randomization
Distant Metastasis-Free Survival (DMFS)
大体时间：Up to 5 years after randomization

Distant metastasis-free survival is defined as the time from randomization to the occurrence of distant metastasis.
Up to 5 years after randomization
Incidence and Severity of Cardiac Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
大体时间：Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years

Acute cardiac toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late cardiac toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of cardiac toxicity will be compared between treatment groups.
Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years
Incidence and Severity of Pulmonary Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
大体时间：Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years

Acute pulmonary toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late pulmonary toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of pulmonary toxicity will be compared between the two treatment groups.
Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 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。

赞助

Mahidol University

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)

2027年7月1日

初级完成 (估计的)

2032年7月1日

研究完成 (估计的)

2036年7月1日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 587/2569(IRB2)

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

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