Clinical trial · Interventional
Hypofractionated Regional Nodal Irradiation in Breast Cancer
NCT06443359CI-TRIAL-00108807active not 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)
This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.
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 |
|---|---|---|---|
| hypofractionated radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes
- description
- Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
- interventionNames
- Radiation: hypofractionated radiation
- type
- EXPERIMENTAL
- label
- Group 2: axillary lymph node dissection
- description
- Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
- interventionNames
- Radiation: hypofractionated radiation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age ≥ 18 years old * Life expectancy of \>5 years * ECOG (Zubrod) performance status 0-1 * Histologically confirmed invasive carcinoma of the breast, including ductal, lobular, mammary, medullary, and tubular histologies * Clinical T stage of cT0, cT1, cT2, or cT3 * Clinical N stage of cN0, cN1, or cN2a * Clinical M stage of cM0Definitive surgery must be performed (either partial mastectomy or mastectomy without immediate reconstruction) with negative surgical margins (defined as no invasive tumor or DCIS on ink). * Must have pathologic T stage of pT1, pT2, or pT3, or if receiving neoadjuvant chemotherapy, ypT0, ypTis, ypT1, ypT2, or ypT3 * Pathologic N stage of pN0, pN1, pN2a, or pN3a, or if receiving neoadjuvant chemotherapy, ypN0,ypN1, ypN2, or ypN3a) NOTE: any patient with clinically involved but undissected lymph nodes that would require a radiation boost will not be eligible. * The radiation oncologist is planning to treat the breast/chest wall and ipsilateral regional lymphatics (including the axillary, supraclavicular, and internal mammary chains) * Patient is able to understand and willing to sign an IRB approved written informed consent document * All dosimetric constraints outlined in protocol section 3.5 can be met Exclusion Criteria: * Clinical or pathologic T4 disease, including inflammatory breast cancer * Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemotherapy, ypN2b, ypN3b, or ypN3c disease * Radiologic evidence of gross residual disease * History of prior ipsilateral breast cancer (invasive disease or DCIS) * Active or history of another malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix * Prior history of radiation therapy to the neck, breast, or thorax. Prior radioactive oral iodine is permitted. * History of active collagen vascular disease including systemic lupus erythematosis, scleroderoma, or dermatomyositis with an elevated CK level * Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential. * The patient is a prisoner.
References
Publications (0)
Data not yet available
No reference posted for this study.