Clinical trial · Interventional
The Postoperative Radiotherapy in N1 Breast Cancer Patients
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
NCT05440149CI-TRIAL-00083141PORT-N1recruitingPhase 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)
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No PMRT for mastectomy / No regional RT for BCS | Radiation | — | UNRESOLVED |
| PMRT for mastectomy / WBI + Regional RT for BCS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The Control group
- description
- * If patients received mastectomy, post-mastectomy radiation therapy (PMRT) should be performed. * If patients received breast conserving surgery (BCS), whole breast irradiation (WBI) + Regional radiotherapy (RT) should be performed.
- interventionNames
- Radiation: PMRT for mastectomy / WBI + Regional RT for BCS
- type
- EXPERIMENTAL
- label
- The Experimental group
- description
- * If patients received mastectomy, No PMRT should be performed. * If patients received BCS, WBI alone should be performed.
- interventionNames
- Radiation: No PMRT for mastectomy / No regional RT for BCS
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 19 years or older. * A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer. * Patient with stage pN1 after surgery on histopathologic examination. * However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes. * Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive. * Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive. * Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2. * Patients who agreed to participate in the study. Exclusion Criteria: * Patients who have received prior \[neoadjuvant\] chemotherapy. * Patients receiving radiation therapy for salvage or palliative purposes. * Patients with stage T4. * Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases. * Male breast cancer patient. * Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region. * Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer. * Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.
References
Publications (1)
- BACKGROUNDLee TH, Chang JH, Jang BS, Kim JS, Kim TH, Park W, Kim YB, Kim SS, Han W, Lee HB, Shin KH. Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy. BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0. PMID 36384573