RecruitingNot ApplicableNCT05976412

Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer

Sponsor

Ruijin Hospital

Enrollment

1,355 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation to the lymph node regions near the breast (regional nodal irradiation) reduces cancer recurrence in women with early breast cancer who have no lymph node involvement but have other high-risk features. **You may be eligible if...** - You are a woman over 18 years old - You had surgery for invasive breast cancer (either lumpectomy or mastectomy) - Your lymph nodes tested negative (no cancer spread to nodes) - Your cancer is staged T1–T3, N0, M0 - You have at least two of these high-risk features: tumor larger than 2 cm, tumor in the inner or central part of the breast, Ki-67 above 14% (fast-growing cells), or blood/lymph vessel invasion - You have good overall health (KPS ≥ 80) **You may NOT be eligible if...** - You have lymph node involvement - You have distant metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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