RecruitingPhase 3NCT05059379

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery

Sponsor

Fudan University

Enrollment

1,650 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Radiotherapy; Complications Effect of Radiation Therapy

Summary

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares radiation to the entire supraclavicular (collarbone) lymph node region versus just the inner portion in women with invasive breast cancer who need lymph node radiation after surgery. **You may be eligible if...** - You have newly diagnosed invasive breast cancer with stage T1–T4, N2–N3 features (or stage III with neoadjuvant chemotherapy) - You had breast-conserving surgery or mastectomy with adequate lymph node removal - You received at least 6 cycles of standard chemotherapy - Your performance status is good (ECOG 0–1) - You are enrolled within 12 weeks of your last surgery or chemotherapy **You may NOT be eligible if...** - You had supraclavicular lymph node involvement at diagnosis (N3c) - You have distant metastases or bilateral breast cancer - You have previously had breast cancer on the other side - You have insufficient lymph node removal or positive sentinel nodes that were not removed 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

RADIATIONEntire supraclavicular lymph node radiotherapy

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.

RADIATIONMedial supraclavicular lymph node radiotherapy

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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