RecruitingNot ApplicableNCT04517266

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Patients According to Clinical-genomic Model: an Open Label, Non-inferior Randomized Controlled Trial


Sponsor

Ruijin Hospital

Enrollment

214 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether leaving out radiation to the internal mammary lymph nodes (nodes along the breastbone) is safe for early-stage breast cancer patients with 1 to 3 positive lymph nodes, potentially reducing side effects without worsening outcomes. **You may be eligible if...** - You have been diagnosed with invasive breast cancer - You had surgery (either mastectomy or lumpectomy) and removal of lymph nodes under your arm - You had 1 to 3 lymph nodes that tested positive for cancer - Your cancer has certain high-risk features such as a large tumor, young age, or triple-negative or HER2+ status **You may NOT be eligible if...** - You had 4 or more positive lymph nodes - You had distant metastases at diagnosis - Your cancer spread to the skin or chest wall 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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Interventions

RADIATIONomit of IMI group

clincial high risk breast (≥2 risk factors)patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.

RADIATIONIMI group

clincial high risk breast (≥2 risk factors)patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.


Locations(1)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

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NCT04517266


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