Clinical trial · Interventional
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions
NCT02276885CI-TRIAL-00099877active not recruitingN/AResults postedClinicalTrials.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 test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBI Radiotherapy 6 Gy | Radiation | — | UNRESOLVED |
| PBI Radiotherapy 8 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PBI Radiotherapy 6 Gy
- description
- Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
- interventionNames
- Radiation: PBI Radiotherapy 6 Gy
- type
- EXPERIMENTAL
- label
- PBI Radiotherapy 8 Gy
- description
- Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
- interventionNames
- Radiation: PBI Radiotherapy 8 Gy
Primary outcomes (1)
- measure
- Percentage of Participants With Grade 2 or 3 Fibrosis
- timeFrame
- 60 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal women defined as either: 1. at least 2 years without menstrual period 2. patients older than 50 with serological evidence of post-menopausal status 3. hysterectomized patients of any age with FSH confirmation of post- menopausal status * pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis: 1. Screen-detected 2. Low to intermediate nuclear grade 3. \< 2.5cm in size 4. Resected with negative margins at \>3mm) * clinically N0 or pN0 or sentinel node negative breast cancer Exclusion Criteria: * previous radiation therapy to the ipsilateral breast * presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
References
Publications (0)
Data not yet available
No reference posted for this study.