Clinical trial · Interventional
De-escalation of RNI in Breast Cancer Patients With pN0 After Neoadjuvant Therapy
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients With Pathological Nodal Complete Response After Neoadjuvant Therapy
NCT07724769CI-TRIAL-00119291OMIT-RNInot yet recruitingN/AClinicalTrials.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)
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients with Pathological Nodal Complete Response After Neoadjuvant Therapy
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Experimental Arm
- description
- Patients will receive whole breast irradiation (WBI) following breast-conserving surgery or chest wall irradiation (CWI) following mastectomy, without regional nodal irradiation (RNI).
- interventionNames
- Radiation: Adjuvant Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B:Control Arm
- description
- Patients will receive standard whole breast irradiation (WBI) or chest wall irradiation (CWI) combined with standard regional nodal irradiation (RNI) according to institutional protocol and current international guidelines.
- interventionNames
- Radiation: Adjuvant Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \>= 18 years old. * Histologically confirmed invasive breast cancer, cT1-3 N1M0 according to the 8th AJCC edition. * Biopsy-proven cN1 disease at diagnosis. * Completion of standard neoadjuvant systemic therapy. * Surgical treatment of breast and axilla. * Pathologically confirmed ypN0 status. * ECOG performance status 0-2. * Suitable for adjuvant radiotherapy. * Signed informed consent. Exclusion Criteria: * Metastatic disease (M1). * Prior thoracic irradiation. * Pregnancy or lactation. * Severe uncontrolled comorbid illness. * Any contraindication to radiotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.