Clinical trial · Interventional
Radiation After No Axillary Nodal Sampling
RADIation After no Axillary Nodal Sampling (RADIANS)
- 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 single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.
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 |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Invasive Ductal Carcinoma of Female Breast | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial Breast Irradiation (PBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early-Stage Breast Cancer Patients
- description
- Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).
- interventionNames
- Radiation: Partial Breast Irradiation (PBI)
Primary outcomes (1)
- measure
- Rate of Axillary Recurrence
- timeFrame
- Up to Year 5-post-radiation
- description
- Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.
Secondary outcomes (8)
- measure
- Rate of Local Recurrence
- timeFrame
- Up to Year 5-post-radiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals assigned Female at birth, age 40 and older * Breast conserving surgery without SLNB or ALND * All patients should be capable of giving informed consent, * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Histologically confirmed invasive ductal carcinoma * Individuals with pathologic tumor size \<3cm * Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial. * Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging) * Electrocorticography (ECOG) performance status 0-2 Exclusion Criteria: * Male * Transgender or non-binary individuals. * Mastectomy * Metastatic disease * History of ipsilateral or contralateral breast cancer. * Obstacles to obtaining informed consent or undergoing regular follow-up
References
Publications (0)
Data not yet available