Clinical trial · Interventional
Ultra-hypofractionated Irradiation of the Whole Breast (WBI) Compared to Partial Breast Irradiation (PBI)
Ultra-hypofractionated Radiotherapy for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial Breast Irradiation | Radiation | — | UNRESOLVED |
| Ultra-hypofractionated WBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Partial Breast Irradiation
- interventionNames
- Radiation: Partial Breast Irradiation
- type
- EXPERIMENTAL
- label
- Whole Breast Irradiation
- interventionNames
- Radiation: Ultra-hypofractionated WBI
Primary outcomes (2)
- measure
- Acute Radiation Toxicity
- timeFrame
- From the start of radiotherapy up to 6 months.
- description
- Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Breast-conserving surgery * Invasive ductal carcinoma * Age ≥ 50 * Tumor size ≤ 3 cm * R0 resection * Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm * pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi * Hormone receptor status - any * Histological grade G1 or G2 Exclusion Criteria: * Neoadjuvant systemic therapy * TNBC (triple-negative breast cancer) * Extensive intraductal component (EIC) * Lymphovascular invasion (LVI) * associated DCIS \> 2.5 cm in size or high nuclear grade
References
Publications (0)
Data not yet available