Active, not recruiting
March 17, 2021
March 17, 2021
The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.
This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.
|Experimental: Internal mammary node irradiation
Radiation: Internal mammary node irradiation
Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
|Active Comparator: No internal mammary node irradiation
Radiation: No internal mammary node irradiation
Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Inclusion Criteria: 1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed. Exclusion Criteria: 1. Neoadjuvant chemotherapy 2. Bilateral breast cancer 3. Distant metastasis 4. History of other malignancy 5. Involvement of supraclavicular nodes or internal mammary nodes at diagnosis
Korea, Republic of
Yonsei Severance Hospital
Principal Investigator: Yong Bae Kim, MD, PhD Severance Hospital