Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal mammary node irradiation | Experimental |
| |
| No internal mammary node irradiation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal mammary node irradiation | Radiation | Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of overall survival | 7 years | |
| breast cancer-specific survival | 7 years | |
| Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yong Bae Kim, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34695841 | Derived | Kim YB, Byun HK, Kim DY, Ahn SJ, Lee HS, Park W, Kim SS, Kim JH, Lee KC, Lee IJ, Kim WT, Shin HS, Kim K, Shin KH, Nam CM, Suh CO. Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):96-105. doi: 10.1001/jamaoncol.2021.6036. |
Not provided
Not provided
Analytic codes will be shared upon reasonable request to corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No internal mammary node irradiation | Radiation | Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery |
|
| 7 years |
| D017437 |
| Skin and Connective Tissue Diseases |