Clinical trial · Interventional
Radiation Therapy for ypN0 Breast Cancer
Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
NCT04240548CI-TRIAL-00051006unknownPhase 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 is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy
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 |
|---|---|---|---|
| Regional Nodal Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm: A
- description
- regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
- interventionNames
- Radiation: Regional Nodal Irradiation
- type
- NO_INTERVENTION
- label
- Arm: B
- description
- chest wall or whole breast only irradiation
Primary outcomes (1)
- measure
- Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
- timeFrame
- time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years
- description
- axillary, internal mammary or supraclavicular recurrences
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * WHO performance status 0-1 * Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis * Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan * Pathologic confirmation using, FNAC, core biopsy or excisional biopsy * ER, PR, Her2 neu and Ki67 status should be available for all patients * All patients should have received standard preoperative chemotherapy prior to surgery * At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla * Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization Exclusion Criteria: * Poor performance status * Definitive clinical or radiologic evidence of metastatic disease * T4 tumors including inflammatory breast cancer * N3 disease detected clinically or by imaging * Patients with histologically positive axillary nodes after preoperative chemotherapy * Positive surgical margin after definitive surgery * Previous ipsilateral or contralateral breast cancer * Previous chest wall or breast irradiation * Second primary cancer * Active connective tissue disease
References
Publications (0)
Data not yet available
No reference posted for this study.