Clinical trial · Interventional
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
NCT02375048CI-TRIAL-00035420terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): number of enrollments not reached in the estimated time
Summary
Brief summary (as posted)
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
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 |
|---|---|---|---|
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
| Hypofractionated WBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hypofractionated WBI
- description
- Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).
- interventionNames
- Radiation: Hypofractionated WBI
- type
- EXPERIMENTAL
- label
- Accelerated Partial Breast Irradiation
- description
- Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).
- interventionNames
- Radiation: Accelerated Partial Breast Irradiation
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 55\< Age \<70 * Tumor size ≤ 2 cm * pN0 (SN biopsy or ALND) * ER/PgR positive * Margins \> 5 mm (either at initial surgery or at re-excision) * Clips placed in the surgical bed (minimum of 4 clips) * Unicentric only * No lymphovascular invasion * Any grade * No extensive intraductal component (\>25%) * Written informed consent Exclusion Criteria: * Prior thoracic radiation therapy * Oncoplastic surgery / No clips in the surgical bed * Multicentric cancer * Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
References
Publications (0)
Data not yet available
No reference posted for this study.