Clinical trial · Interventional
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
NCT04803266CI-TRIAL-00050718unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internal mammary node irradiation | Radiation | — | UNRESOLVED |
| No internal mammary node irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Internal mammary node irradiation
- interventionNames
- Radiation: Internal mammary node irradiation
- type
- ACTIVE_COMPARATOR
- label
- No internal mammary node irradiation
- interventionNames
- Radiation: No internal mammary node irradiation
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 7 years
Secondary outcomes (3)
- measure
- Rates of overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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. PMID 34695841