RecruitingPhase 3NCT05440149

The Postoperative Radiotherapy in N1 Breast Cancer Patients

The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial


Sponsor

Seoul National University Hospital

Enrollment

1,106 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether postoperative radiation therapy benefits women with early breast cancer that has spread to a limited number of nearby lymph nodes (called pN1 — 1 to 3 positive nodes) after breast-conserving surgery or mastectomy. It aims to clarify whether radiation is necessary for all these patients or only some. **You may be eligible if:** - You are a woman aged 19 or older - You have had surgery (breast-conserving or mastectomy) for invasive breast cancer - After surgery, pathology showed 1 to 3 positive lymph nodes (pN1 stage) - You are receiving or planning to receive hormone therapy (if your cancer is hormone receptor-positive) - Your cancer type is appropriate for the study - You are in good overall health (ECOG 0–2) **You may NOT be eligible if:** - You had 4 or more positive lymph nodes after surgery - You have not agreed to participate or cannot provide consent - Your cancer characteristics fall outside the study criteria 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONNo PMRT for mastectomy / No regional RT for BCS

* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.

RADIATIONPMRT for mastectomy / WBI + Regional RT for BCS

* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.


Locations(1)

Seoul National University Hospital

Seoul, Jongro-gu, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05440149


Related Trials