Recruiting

Internal Mammary Lymph Nodes Irradiation for High-risk Breast Cancer

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What is being tested

internal mammary nodal irradiation

+ No internal mammary node irradiation

Radiation
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorFujian Medical University Union Hospital
Study ContactYong Yang, M.S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2024

Actual date on which the first participant was enrolled.

This study focuses on women with high-risk breast cancer who have already received a type of cancer treatment called neoadjuvant chemotherapy. These women have cancer that has spread to certain lymph nodes. The study investigates whether adding a specific type of radiation treatment, called internal mammary lymph node irradiation (IMNI), to the usual radiation therapy can be beneficial. The goal is to see if IMNI improves outcomes for these patients by potentially reducing the chance of cancer returning or spreading. Participants in this study receive regional nodal irradiation alongside radiation to the breast or chest wall. They are randomly assigned to two groups: one receives the additional IMNI radiation, while the other does not. By comparing the results of the two groups, researchers aim to assess the impact of IMNI on the progression of the disease. The study does not specify immediate risks or benefits of IMNI, but the goal is to understand whether its inclusion provides significant help in treating high-risk breast cancer.

Official TitleInternal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial
NCT06559696
Principal SponsorFujian Medical University Union Hospital
Study ContactYong Yang, M.S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

722 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
Histologically confirmed invasive breast cancer

Underwent neoadjuvant chemotherapy

Eastern Cooperative Oncology Group Performance Status Scale 0-2

ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy

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5 exclusion criteria prevent from participating
Without neoadjuvant chemotherapy

Distant metastases

Simultaneous bilateral breast cancer

Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
chest wall/whole breast and supraclavicular+-axillary nodal plus internal mammary nodal irradiation

Group II

Active Comparator
chest wall/whole breast and supraclavicular+-axillary nodal irradiation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fujian Medical University Union Hospital

Fuzhou, ChinaOpen Fujian Medical University Union Hospital in Google Maps
Recruiting
One Study Center