Clinical trial · Interventional
Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity
NCT01024582CI-TRIAL-00029680PAPBIcompletedN/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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| fine-needle aspiration | Procedure | — | UNRESOLVED |
| image-guided radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- accelerated partial breast irradiation
- description
- pre-operative radiation of the in situ tumor in the breast
- interventionNames
- Procedure: biopsy
- Procedure: fine-needle aspiration
- Radiation: accelerated partial breast irradiation
- Radiation: image-guided radiation therapy
Primary outcomes (1)
- measure
- local recurrence
- timeFrame
- 5 years
- description
- Local recurrences should not exceed 4% at 5 years of follow-up
Secondary outcomes (3)
- measure
- breast fibrosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer * Must have undergone a sentinel node procedure prior to irradiation PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (1)
- DERIVEDvan der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17. PMID 25701298