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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
722
chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGDisease free survival
From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause
Time frame: 5 years
Overall survival
From date of enrollment until the date of death from any cause.
Time frame: 5 years
Distant metastasis-free survival
The time of randomization to the first recurrence in a distant site.
Time frame: 5 years
Local-regional recurrence-free survival
The time of randomization to the first recurrence in the ipsilateral breast or chest wall and the regional nodal area.
Time frame: 5 years
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