Internal Mammary Lymph Nodes Irradiation for High-risk Breast Cancer
internal mammary nodal irradiation
+ No internal mammary node irradiation
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.722 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Fujian Medical University Union Hospital
Fuzhou, ChinaOpen Fujian Medical University Union Hospital in Google Maps