Clinical trial · Interventional
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
NCT01717261CI-TRIAL-00070963SPORTcompletedPhase 1ClinicalTrials.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)
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
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 |
|---|---|---|---|
| Single Pre-Operative Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Pre-Operative Radiation Therapy
- interventionNames
- Radiation: Single Pre-Operative Radiation Therapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 6 months
- description
- Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
Secondary outcomes (2)
- measure
- Chronic toxicity
- timeFrame
- 2 years
- description
- Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged 60 years or older. * Invasive ductal carcinoma. * Unifocal disease. * Tumors less than 2cm. * No clinical evidence of nodal disease. * Estrogen receptor status (ER) positive. * Her2 negative. Exclusion Criteria: * Age less than 60 years. * BRCA 1 and/or BRCA 2 mutation. * Tumour histology limited to lobular carcinoma only. * Neoadjuvant hormonal manipulation or chemotherapy. * More than one primary tumour in different quadrants of the same breast. * Inability to view tumor on imaging.
References
Publications (0)
Data not yet available
No reference posted for this study.