NCT06559696

Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy

Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 722 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

Detailed description

This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	internal mammary nodal irradiation	chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
RADIATION	No internal mammary node irradiation	chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

Timeline

• Start date: 2024-07-15
• Primary completion: 2032-07-15
• Completion: 2032-07-15
• First posted: 2024-08-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China