Clinical trial · Interventional
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery
- 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)
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole breast and nodal irradiation | Radiation | — | UNRESOLVED |
| Whole breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole breast irradiation
- description
- Post-lumpectomy radiotherapy to the whole breast alone.
- interventionNames
- Radiation: Whole breast irradiation
- type
- ACTIVE_COMPARATOR
- label
- Whole breast and nodal irradiation
- description
- Post-lumpectomy radiotherapy to the whole breast and regional lymph node.
- interventionNames
- Radiation: Whole breast and nodal irradiation
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 7 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven invasive carcinoma of the breast. * One to three positive axillary lymph nodes (pN1) proven in pathologic specimen. * Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane. * Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor. * Administering anti-HER2 therapy in cases with HER2-positive tumor. Exclusion Criteria: * Metastases in supraclavicular or internal mammary lymph nodes. * Metastases in distant organs. * Neoadjuvant chemotherapy or hormone therapy before surgery. * Not receiving adjuvant anthracycline and taxane. * Bilateral breast cancer * Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes. * Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.
References
Publications (1)
- DERIVEDKim N, Park W, Kim H, Cho WK, Ahn SJ, Kim MY, Park SH, Lee IJ, Ha I, Kim JH, Kim TH, Lee KC, Lee HS, Kim TG, Shin KH, Lee JH, Jung J, Cho O, Kim YB, Kim ES, Jo IY, Koo T, Kim K, Park HJ, Shin YJ, Ha B, Kwon J, Lee JH, Moon S. Patient-Reported Outcomes Between Whole-Breast Plus Regional Irradiation and Whole-Breast Irradiation Only in pN1 Breast Cancer After Breast-Conserving Surgery and Taxane-Based Chemotherapy: A Randomized Phase 3 Clinical Trial (KROG 17-01). Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):341-351. doi: 10.1016/j.ijrobp.2024.09.017. Epub 2024 Sep 24. PMID 39326505