NCT05440149

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,106 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC) The control group: * If patients received BCS, WBI+Regional RT * If patients received mastectomy, PMRT The experimental group: * If patients received breast conserving surgery, WBI alone * If patients received mastectomy, No PMRT

Conditions

• Radiotherapy
• Breast Cancer

Interventions

Type	Name	Description
RADIATION	No 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.
RADIATION	PMRT 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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-12-31
• Completion: 2033-12-31
• First posted: 2022-06-30
• Last updated: 2024-11-29

Locations

1 site across 1 country: South Korea