NCT07527689

Ultra-Hypofractionated vs Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in High Risk Breast Cancer

A Multicenter, Randomized, Controlled Phase III Clinical Trial Comparing Ultra-Hypofractionated Versus Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in Post-operative Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,950 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.

Detailed description

The study intervention is RNI delivered using modern techniques, including Intensity-Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT) or Intensity-Modulated Proton Therapy (IMPT). Technical parameters for treatment delivery, such as target delineation and OARs dose constraints, will be standardized across both arms. The investigational component is the randomized comparison of the ultra-hypofractionated regimen (26 Gy in 5 fractions over one week) and the moderate hypofractionated regimen (40 Gy in 15 fractions over three weeks).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Ultra-hypofractionated Regional Nodal Irradiation	26 Gy in 5 fractions over 1 week (5.2 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Sequential tumor bed boost of 10.4 Gy in 2 fractions (5.2 Gy per fraction) for patients after breast-conserving surgery.
RADIATION	Moderate Hypofractionated Regional Nodal Irradiation	40.05 Gy in 15 fractions over 3 weeks (2.67 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Simultaneous Integrated Boost of 48 Gy in 15 fractions (3.2 Gy per fraction) for patients after breast-conserving surgery.

Timeline

• Start date: 2026-03-30
• Primary completion: 2034-03-30
• Completion: 2039-03-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China